Lactated Ringer Versus Albumin in Early Sepsis Therapy

Septic Shock Clinical Trial

— RASP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337934
• Other study ID #: 360/10
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2011
• Last updated: April 3, 2018
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic

Intervention

Drug:
• Lactated Ringer
Lactated Ringer
• Albumin
Albumin 4%

Locations

Country	Name	City	State
Brazil	Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo	Sao Paulo	Sao Paulo/SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leão WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in 7 days for any cause		day 7
Secondary	Evaluation of sequential organ failure assessment (SOFA) score		from day 1 until day 7 of care in ICU
Secondary	ICU length of stay		day 28
Secondary	hospital length of stay		day 28
Secondary	ventilator-free days		day 28
Secondary	Needing of renal replacement therapy		day 28
Secondary	days free of vasopressor		day 28
Secondary	Mortality in 28-days		28 days after randomization