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NCT Number: NCT01337934

Lactated Ringer Versus Albumin in Early Sepsis Therapy

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Severe Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo

São Paulo, Sao Paulo/SP, 01246000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age equal or higher than 18 years-old
  • Severe sepsis or septic shock into 6 hours of evolution
  • Written informed consent

Exclusion criteria

  • Shock from other causes
  • Adverse reactions to human albumin
  • Previous fluid resuscitation during current disease
  • Previous use of albumin in the last 72 hours
  • Religion objection
  • Enrollment in another study
  • Traumatic brain injury
  • Hepatic cirrhosis
  • End stage renal disease
  • Plasmapheresis
  • End of life patients

Treatment and study plan

Lactated Ringer

Drug

Lactated Ringer

ALBUMIN

Drug

Albumin 4%

Primary outcomes

  1. Mortality in 7 days for any cause

    Time frame: day 7

Secondary outcomes

  1. Evaluation of sequential organ failure assessment (SOFA) score

    Time frame: from day 1 until day 7 of care in ICU

  2. ICU length of stay

    Time frame: day 28

  3. hospital length of stay

    Time frame: day 28

  4. ventilator-free days

    Time frame: day 28

  5. Needing of renal replacement therapy

    Time frame: day 28

  6. days free of vasopressor

    Time frame: day 28

  7. Mortality in 28-days

    Time frame: 28 days after randomization

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial

Acronym: RASP

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Apr 19, 2011
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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