title: Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial.
abstract: BACKGROUND
  Constipation is a common problem in intensive care units. We assessed the efficacy and safety of laxative therapy aiming to promote daily defecation in reducing organ dysfunction in mechanically ventilated patients.
  
  
  METHODS
  We conducted a prospective, randomized, controlled, nonblinded phase II clinical trial at two general intensive care units. Patients expected to remain ventilated for over 3 days were randomly assigned to daily defecation or control groups. The intervention group received lactulose and enemas to produce 1-2 defecations per day. In the control group, absence of defecation was tolerated up to 5 days. Primary outcome was the change in Sequential Organ Failure Assessment (SOFA) score between the date of enrollment and intensive care unit discharge, death or day 14.
  
  
  RESULTS
  We included 88 patients. Patients in the treatment group had a higher number of defecations per day (1.3 ± 0.42 versus 0.7 ± 0.56, p < 0.0001) and lower percentage of days without defecation (33.1 ± 15.7% versus 62.3 ± 24.5%, p < 0.0001). Patients in the intervention group had a greater reduction in SOFA score (-4.0 (-6.0 to 0) versus -1.0 (-4.0 to 1.0), p = 0.036) with no difference in mortality rates or in survival time. Adverse events were more frequent in the treatment group (4.5 (3.0-8.0) versus 3.0 (1.0-5.7), p = 0.016), including more days with diarrhea (2.0 (1.0-4.0) versus 1.0 (0-2.0) days, p < 0.0001). Serious adverse events were rare and did not significantly differ between groups.
  
  
  CONCLUSIONS
  Laxative therapy improved daily defecation in ventilated patients and was associated with a greater reduction in SOFA score.
  
  
  BACKGROUND
  Clinical Trials.gov NCT01607060, registered 24 May 2012.
authors.affiliation: Disciplina de Anestesiologia, Dor e Terapia Intensiva, Universidade Federal de São Paulo, Rua Napoleão de Barros, 715 - 6° andar - Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil. rpdeazevedo@yahoo.com.br.
authors.forename: Rodrigo Palacio
authors.initials: RP
authors.lastname: de Azevedo
authors.affiliation: Disciplina de Anestesiologia, Dor e Terapia Intensiva, Universidade Federal de São Paulo, Rua Napoleão de Barros, 715 - 6° andar - Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil. flaviogrf@yahoo.com.br.
authors.forename: Flávio Geraldo Resende
authors.initials: FG
authors.lastname: Freitas
authors.affiliation: Disciplina de Anestesiologia, Dor e Terapia Intensiva, Universidade Federal de São Paulo, Rua Napoleão de Barros, 715 - 6° andar - Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil. elainemogi@yahoo.com.br.
authors.forename: Elaine Maria
authors.initials: EM
authors.lastname: Ferreira
authors.affiliation: Disciplina de Anestesiologia, Dor e Terapia Intensiva, Universidade Federal de São Paulo, Rua Napoleão de Barros, 715 - 6° andar - Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil. lucianoazevedo@uol.com.br.
authors.forename: Luciano Cesar
authors.initials: LC
authors.lastname: Pontes de Azevedo
authors.affiliation: Disciplina de Anestesiologia, Dor e Terapia Intensiva, Universidade Federal de São Paulo, Rua Napoleão de Barros, 715 - 6° andar - Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil. frmachado@unifesp.br.
authors.forename: Flávia Ribeiro
authors.initials: FR
authors.lastname: Machado
mesh_terms: D003248:Constipation / Q000188:drug therapy; D003422:Critical Care / Q000379:methods; D003672:Defecation / Q000187:drug effects; D004733:Enema; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007792:Lactulose / Q000008:administration & dosage / Q000627:therapeutic use*; D054368:Laxatives / Q000008:administration & dosage / Q000627:therapeutic use*; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D009102:Multiple Organ Failure / Q000517:prevention & control*; D063305:Organ Dysfunction Scores; D012121:Respiration, Artificial
chemical_list: D054368:Laxatives; D007792:Lactulose