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Lactated Ringer Versus Albumin in Early Sepsis Therapy

NCT01337934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2018-04-05

No results posted yet for this study

Summary

The use of albumin in critical ill patients is a matter of controversy. A large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. In Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids over colloids. But recently, a retrospective analysis of patients with severe sepsis from SAFE study reported that the use of albumin in these patients would be superior, regarding reduction of mortality. The aim of this study is determine whether the use of albumin improve clinical outcomes in patients with severe sepsis or septic shock.

Conditions

  • Septic Shock
  • Severe Sepsis

Interventions

DRUG

Lactated Ringer

Lactated Ringer

DRUG

Albumin

Albumin 4%

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Juliano A Almeida, MD · University of Sao Paulo

  • Ludhmila Hajjar, PhD · University of Sao Paulo

  • Clarice H Park, MD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-10-31
Completion
2017-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337934 on ClinicalTrials.gov