Selective decontamination of the digestive tract to prevent postoperative infection: A randomized placebo-controlled trial in liver transplant patients
OBJECTIVETo determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver. DESIGNRandomized, double-blind, placebo-controlled study. SETTINGTwo academic teaching hospitals. PATIENTSAdult patients undergoing elective live...
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| Veröffentlicht in: | Critical care medicine 2002-06, Vol.30 (6), p.1204-1209 |
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| creator | Zwaveling, Jan H Maring, John K Klompmaker, Ids J Haagsma, Elizabeth B Bottema, Jan T Laseur, M Winter, Heinrich L. J van Enckevort, Petra J TenVergert, Els M Metselaar, Herold J Bruining, H. A Slooff, Maarten J. H |
| description | OBJECTIVETo determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver.
DESIGNRandomized, double-blind, placebo-controlled study.
SETTINGTwo academic teaching hospitals.
PATIENTSAdult patients undergoing elective liver transplantation26 patients receiving SDD and 29 patients receiving a placebo.
INTERVENTIONSPatients undergoing SDD were administered 400 mg of norfloxacin once daily as soon as they were accepted for transplantation. Postoperative treatment for this group consisted of 2 mg of colistin, 1.8 mg of tobramycin, and 10 mg of amphotericin B, four times daily, combined with an oral paste containing a 2% solution of the same drugs until postoperative day 30. Prophylactic intravenous administration of antibiotics was not part of the SDD regimen in this study. Control patients were given a similar regimen with placebo drugs.
MEASUREMENTSThe mean number of postoperative bacterial and fungal infections in the first 30 days after transplantation was the primary efficacy end point. Days on a ventilator, days spent in the intensive care unit, and medical costs were registered as secondary outcome variables.
MAIN RESULTSOf the 26 patients undergoing SDD, 22 (84.5%) developed an infection in the postoperative study period; in the placebo group (n = 29), these numbers were not significantly different (25 patients, 86%). The mean number of postoperative infectious episodes per patient was also not significantly different1.77 (SDD) vs. 1.93 (placebo). Infections involving Gram-negative aerobic bacteria and Candida species were significantly less frequent in patients receiving SDD (p < .001 and p < .05). Total costs were higher in the group receiving SDD.
CONCLUSIONSSelective decontamination of the digestive tract does not prevent infection in patients undergoing elective liver transplantation and increases the cost of their care. It does, however, affect the type of infection. Infections with Gram-negative bacilli and with Candida species are replaced by infections with Gram-positive cocci. |
| doi_str_mv | 10.1097/00003246-200206000-00004 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_71835942</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>71835942</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4114-d47d7c8a33905ccf37e63e43d565f566789db8a64b504e95d76aec5b7a5566f03</originalsourceid><addsrcrecordid>eNp1Uk1vFSEUJcbGPqt_wbDR3SgMX4O7pqmtSRMX1TVhmDs-lBlG4LXRP-LfLfPe067KhnDuOYd7OSCEKXlPiVYfSF2s5bJpCWmJrKdmhfgztKGC1UOr2XO0IUSThnHNTtHLnH8QQrlQ7AU6pS1RrZR6g_7eQgBX_B3gAVyci538bIuPM44jLtsK---Q94SSrCu4RLwkuIO54CXmEhdIdl_287g6xfkjPsfJzkOc_B8Y8BKsgz42q3uKIVSoJG9DFeBQhWk1nnOlrZbVq1rnV-hktCHD6-N-hr59uvx6cd3cfLn6fHF-0zhOKW8GrgblOsuYJsK5kSmQDDgbhBSjkFJ1eug7K3kvCActBiUtONErK2p1JOwMvTv4Lin-2tVBzeSzg1CbgbjLRtGOCc3bSuwORJdizglGsyQ_2fTbUGLWUMy_UMz_UPYQr9I3xzt2_QTDo_CYQiW8PRJsdjaM9Tmcz488pup47dosP_DuYyiQ8s-wu4dktmBD2ZqnPgV7ALIZp7E</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>71835942</pqid></control><display><type>article</type><title>Selective decontamination of the digestive tract to prevent postoperative infection: A randomized placebo-controlled trial in liver transplant patients</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><creator>Zwaveling, Jan H ; Maring, John K ; Klompmaker, Ids J ; Haagsma, Elizabeth B ; Bottema, Jan T ; Laseur, M ; Winter, Heinrich L. J ; van Enckevort, Petra J ; TenVergert, Els M ; Metselaar, Herold J ; Bruining, H. A ; Slooff, Maarten J. H</creator><creatorcontrib>Zwaveling, Jan H ; Maring, John K ; Klompmaker, Ids J ; Haagsma, Elizabeth B ; Bottema, Jan T ; Laseur, M ; Winter, Heinrich L. J ; van Enckevort, Petra J ; TenVergert, Els M ; Metselaar, Herold J ; Bruining, H. A ; Slooff, Maarten J. H</creatorcontrib><description>OBJECTIVETo determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver.
DESIGNRandomized, double-blind, placebo-controlled study.
SETTINGTwo academic teaching hospitals.
PATIENTSAdult patients undergoing elective liver transplantation26 patients receiving SDD and 29 patients receiving a placebo.
INTERVENTIONSPatients undergoing SDD were administered 400 mg of norfloxacin once daily as soon as they were accepted for transplantation. Postoperative treatment for this group consisted of 2 mg of colistin, 1.8 mg of tobramycin, and 10 mg of amphotericin B, four times daily, combined with an oral paste containing a 2% solution of the same drugs until postoperative day 30. Prophylactic intravenous administration of antibiotics was not part of the SDD regimen in this study. Control patients were given a similar regimen with placebo drugs.
MEASUREMENTSThe mean number of postoperative bacterial and fungal infections in the first 30 days after transplantation was the primary efficacy end point. Days on a ventilator, days spent in the intensive care unit, and medical costs were registered as secondary outcome variables.
MAIN RESULTSOf the 26 patients undergoing SDD, 22 (84.5%) developed an infection in the postoperative study period; in the placebo group (n = 29), these numbers were not significantly different (25 patients, 86%). The mean number of postoperative infectious episodes per patient was also not significantly different1.77 (SDD) vs. 1.93 (placebo). Infections involving Gram-negative aerobic bacteria and Candida species were significantly less frequent in patients receiving SDD (p < .001 and p < .05). Total costs were higher in the group receiving SDD.
CONCLUSIONSSelective decontamination of the digestive tract does not prevent infection in patients undergoing elective liver transplantation and increases the cost of their care. It does, however, affect the type of infection. Infections with Gram-negative bacilli and with Candida species are replaced by infections with Gram-positive cocci.</description><identifier>ISSN: 0090-3493</identifier><identifier>EISSN: 1530-0293</identifier><identifier>DOI: 10.1097/00003246-200206000-00004</identifier><identifier>PMID: 12072669</identifier><identifier>CODEN: CCMDC7</identifier><language>eng</language><publisher>Hagerstown, MD: by the Society of Critical Care Medicine and Lippincott Williams & Wilkins</publisher><subject>Adult ; Amphotericin B - therapeutic use ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Anti-Bacterial Agents - therapeutic use ; Antifungal Agents - therapeutic use ; Bacterial Infections - prevention & control ; Biological and medical sciences ; Decontamination - methods ; Digestive System - microbiology ; Double-Blind Method ; Emergency and intensive postoperative care (general aspects). Pathophysiology of surgery ; Female ; Humans ; Intensive care medicine ; Liver Transplantation ; Male ; Medical sciences ; Mycoses - prevention & control ; Norfloxacin - therapeutic use ; Postoperative Complications - prevention & control ; Tobramycin - therapeutic use</subject><ispartof>Critical care medicine, 2002-06, Vol.30 (6), p.1204-1209</ispartof><rights>2002 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins</rights><rights>2002 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4114-d47d7c8a33905ccf37e63e43d565f566789db8a64b504e95d76aec5b7a5566f03</citedby><cites>FETCH-LOGICAL-c4114-d47d7c8a33905ccf37e63e43d565f566789db8a64b504e95d76aec5b7a5566f03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13739020$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12072669$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zwaveling, Jan H</creatorcontrib><creatorcontrib>Maring, John K</creatorcontrib><creatorcontrib>Klompmaker, Ids J</creatorcontrib><creatorcontrib>Haagsma, Elizabeth B</creatorcontrib><creatorcontrib>Bottema, Jan T</creatorcontrib><creatorcontrib>Laseur, M</creatorcontrib><creatorcontrib>Winter, Heinrich L. J</creatorcontrib><creatorcontrib>van Enckevort, Petra J</creatorcontrib><creatorcontrib>TenVergert, Els M</creatorcontrib><creatorcontrib>Metselaar, Herold J</creatorcontrib><creatorcontrib>Bruining, H. A</creatorcontrib><creatorcontrib>Slooff, Maarten J. H</creatorcontrib><title>Selective decontamination of the digestive tract to prevent postoperative infection: A randomized placebo-controlled trial in liver transplant patients</title><title>Critical care medicine</title><addtitle>Crit Care Med</addtitle><description>OBJECTIVETo determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver.
DESIGNRandomized, double-blind, placebo-controlled study.
SETTINGTwo academic teaching hospitals.
PATIENTSAdult patients undergoing elective liver transplantation26 patients receiving SDD and 29 patients receiving a placebo.
INTERVENTIONSPatients undergoing SDD were administered 400 mg of norfloxacin once daily as soon as they were accepted for transplantation. Postoperative treatment for this group consisted of 2 mg of colistin, 1.8 mg of tobramycin, and 10 mg of amphotericin B, four times daily, combined with an oral paste containing a 2% solution of the same drugs until postoperative day 30. Prophylactic intravenous administration of antibiotics was not part of the SDD regimen in this study. Control patients were given a similar regimen with placebo drugs.
MEASUREMENTSThe mean number of postoperative bacterial and fungal infections in the first 30 days after transplantation was the primary efficacy end point. Days on a ventilator, days spent in the intensive care unit, and medical costs were registered as secondary outcome variables.
MAIN RESULTSOf the 26 patients undergoing SDD, 22 (84.5%) developed an infection in the postoperative study period; in the placebo group (n = 29), these numbers were not significantly different (25 patients, 86%). The mean number of postoperative infectious episodes per patient was also not significantly different1.77 (SDD) vs. 1.93 (placebo). Infections involving Gram-negative aerobic bacteria and Candida species were significantly less frequent in patients receiving SDD (p < .001 and p < .05). Total costs were higher in the group receiving SDD.
CONCLUSIONSSelective decontamination of the digestive tract does not prevent infection in patients undergoing elective liver transplantation and increases the cost of their care. It does, however, affect the type of infection. Infections with Gram-negative bacilli and with Candida species are replaced by infections with Gram-positive cocci.</description><subject>Adult</subject><subject>Amphotericin B - therapeutic use</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antifungal Agents - therapeutic use</subject><subject>Bacterial Infections - prevention & control</subject><subject>Biological and medical sciences</subject><subject>Decontamination - methods</subject><subject>Digestive System - microbiology</subject><subject>Double-Blind Method</subject><subject>Emergency and intensive postoperative care (general aspects). Pathophysiology of surgery</subject><subject>Female</subject><subject>Humans</subject><subject>Intensive care medicine</subject><subject>Liver Transplantation</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mycoses - prevention & control</subject><subject>Norfloxacin - therapeutic use</subject><subject>Postoperative Complications - prevention & control</subject><subject>Tobramycin - therapeutic use</subject><issn>0090-3493</issn><issn>1530-0293</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1Uk1vFSEUJcbGPqt_wbDR3SgMX4O7pqmtSRMX1TVhmDs-lBlG4LXRP-LfLfPe067KhnDuOYd7OSCEKXlPiVYfSF2s5bJpCWmJrKdmhfgztKGC1UOr2XO0IUSThnHNTtHLnH8QQrlQ7AU6pS1RrZR6g_7eQgBX_B3gAVyci538bIuPM44jLtsK---Q94SSrCu4RLwkuIO54CXmEhdIdl_287g6xfkjPsfJzkOc_B8Y8BKsgz42q3uKIVSoJG9DFeBQhWk1nnOlrZbVq1rnV-hktCHD6-N-hr59uvx6cd3cfLn6fHF-0zhOKW8GrgblOsuYJsK5kSmQDDgbhBSjkFJ1eug7K3kvCActBiUtONErK2p1JOwMvTv4Lin-2tVBzeSzg1CbgbjLRtGOCc3bSuwORJdizglGsyQ_2fTbUGLWUMy_UMz_UPYQr9I3xzt2_QTDo_CYQiW8PRJsdjaM9Tmcz488pup47dosP_DuYyiQ8s-wu4dktmBD2ZqnPgV7ALIZp7E</recordid><startdate>200206</startdate><enddate>200206</enddate><creator>Zwaveling, Jan H</creator><creator>Maring, John K</creator><creator>Klompmaker, Ids J</creator><creator>Haagsma, Elizabeth B</creator><creator>Bottema, Jan T</creator><creator>Laseur, M</creator><creator>Winter, Heinrich L. J</creator><creator>van Enckevort, Petra J</creator><creator>TenVergert, Els M</creator><creator>Metselaar, Herold J</creator><creator>Bruining, H. A</creator><creator>Slooff, Maarten J. H</creator><general>by the Society of Critical Care Medicine and Lippincott Williams & Wilkins</general><general>Lippincott</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200206</creationdate><title>Selective decontamination of the digestive tract to prevent postoperative infection: A randomized placebo-controlled trial in liver transplant patients</title><author>Zwaveling, Jan H ; Maring, John K ; Klompmaker, Ids J ; Haagsma, Elizabeth B ; Bottema, Jan T ; Laseur, M ; Winter, Heinrich L. J ; van Enckevort, Petra J ; TenVergert, Els M ; Metselaar, Herold J ; Bruining, H. A ; Slooff, Maarten J. H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4114-d47d7c8a33905ccf37e63e43d565f566789db8a64b504e95d76aec5b7a5566f03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adult</topic><topic>Amphotericin B - therapeutic use</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Antifungal Agents - therapeutic use</topic><topic>Bacterial Infections - prevention & control</topic><topic>Biological and medical sciences</topic><topic>Decontamination - methods</topic><topic>Digestive System - microbiology</topic><topic>Double-Blind Method</topic><topic>Emergency and intensive postoperative care (general aspects). Pathophysiology of surgery</topic><topic>Female</topic><topic>Humans</topic><topic>Intensive care medicine</topic><topic>Liver Transplantation</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mycoses - prevention & control</topic><topic>Norfloxacin - therapeutic use</topic><topic>Postoperative Complications - prevention & control</topic><topic>Tobramycin - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zwaveling, Jan H</creatorcontrib><creatorcontrib>Maring, John K</creatorcontrib><creatorcontrib>Klompmaker, Ids J</creatorcontrib><creatorcontrib>Haagsma, Elizabeth B</creatorcontrib><creatorcontrib>Bottema, Jan T</creatorcontrib><creatorcontrib>Laseur, M</creatorcontrib><creatorcontrib>Winter, Heinrich L. J</creatorcontrib><creatorcontrib>van Enckevort, Petra J</creatorcontrib><creatorcontrib>TenVergert, Els M</creatorcontrib><creatorcontrib>Metselaar, Herold J</creatorcontrib><creatorcontrib>Bruining, H. A</creatorcontrib><creatorcontrib>Slooff, Maarten J. H</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Critical care medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zwaveling, Jan H</au><au>Maring, John K</au><au>Klompmaker, Ids J</au><au>Haagsma, Elizabeth B</au><au>Bottema, Jan T</au><au>Laseur, M</au><au>Winter, Heinrich L. J</au><au>van Enckevort, Petra J</au><au>TenVergert, Els M</au><au>Metselaar, Herold J</au><au>Bruining, H. A</au><au>Slooff, Maarten J. H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Selective decontamination of the digestive tract to prevent postoperative infection: A randomized placebo-controlled trial in liver transplant patients</atitle><jtitle>Critical care medicine</jtitle><addtitle>Crit Care Med</addtitle><date>2002-06</date><risdate>2002</risdate><volume>30</volume><issue>6</issue><spage>1204</spage><epage>1209</epage><pages>1204-1209</pages><issn>0090-3493</issn><eissn>1530-0293</eissn><coden>CCMDC7</coden><abstract>OBJECTIVETo determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver.
DESIGNRandomized, double-blind, placebo-controlled study.
SETTINGTwo academic teaching hospitals.
PATIENTSAdult patients undergoing elective liver transplantation26 patients receiving SDD and 29 patients receiving a placebo.
INTERVENTIONSPatients undergoing SDD were administered 400 mg of norfloxacin once daily as soon as they were accepted for transplantation. Postoperative treatment for this group consisted of 2 mg of colistin, 1.8 mg of tobramycin, and 10 mg of amphotericin B, four times daily, combined with an oral paste containing a 2% solution of the same drugs until postoperative day 30. Prophylactic intravenous administration of antibiotics was not part of the SDD regimen in this study. Control patients were given a similar regimen with placebo drugs.
MEASUREMENTSThe mean number of postoperative bacterial and fungal infections in the first 30 days after transplantation was the primary efficacy end point. Days on a ventilator, days spent in the intensive care unit, and medical costs were registered as secondary outcome variables.
MAIN RESULTSOf the 26 patients undergoing SDD, 22 (84.5%) developed an infection in the postoperative study period; in the placebo group (n = 29), these numbers were not significantly different (25 patients, 86%). The mean number of postoperative infectious episodes per patient was also not significantly different1.77 (SDD) vs. 1.93 (placebo). Infections involving Gram-negative aerobic bacteria and Candida species were significantly less frequent in patients receiving SDD (p < .001 and p < .05). Total costs were higher in the group receiving SDD.
CONCLUSIONSSelective decontamination of the digestive tract does not prevent infection in patients undergoing elective liver transplantation and increases the cost of their care. It does, however, affect the type of infection. Infections with Gram-negative bacilli and with Candida species are replaced by infections with Gram-positive cocci.</abstract><cop>Hagerstown, MD</cop><pub>by the Society of Critical Care Medicine and Lippincott Williams & Wilkins</pub><pmid>12072669</pmid><doi>10.1097/00003246-200206000-00004</doi><tpages>6</tpages></addata></record> |
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| ispartof | Critical care medicine, 2002-06, Vol.30 (6), p.1204-1209 |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Adult Amphotericin B - therapeutic use Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Anti-Bacterial Agents - therapeutic use Antifungal Agents - therapeutic use Bacterial Infections - prevention & control Biological and medical sciences Decontamination - methods Digestive System - microbiology Double-Blind Method Emergency and intensive postoperative care (general aspects). Pathophysiology of surgery Female Humans Intensive care medicine Liver Transplantation Male Medical sciences Mycoses - prevention & control Norfloxacin - therapeutic use Postoperative Complications - prevention & control Tobramycin - therapeutic use |
| title | Selective decontamination of the digestive tract to prevent postoperative infection: A randomized placebo-controlled trial in liver transplant patients |
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