Lactated Ringer Versus Albumin in Early Sepsis Therapy (RASP)

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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Severe Sepsis
• Intervention / Treatment: Drug: Lactated Ringer; Drug: Albumin

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo/SP
    • Sao Paulo, Sao Paulo/SP, Brazil, 01246000
      • Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Lactated Ringer; Patients randomized for this group will receive 500 ml of lactated Ringer solution in early phase of sepsis or septic shock (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg, or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension.	Drug: Lactated Ringer; Lactated Ringer
Active Comparator: Albumin; Patients randomized for Albumin group will receive 500 ml of 4% Albumin solution in early phase of sepsis (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension.	Drug: Albumin; Albumin 4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality in 7 days for any cause	day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU length of stay	day 28
hospital length of stay	day 28
Evaluation of sequential organ failure assessment (SOFA) score	from day 1 until day 7 of care in ICU
ventilator-free days	day 28
Needing of renal replacement therapy	day 28
days free of vasopressor	day 28
Mortality in 28-days	28 days after randomization

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Juliano A Almeida, MD, University of São Paulo; Study Director: Ludhmila Hajjar, PhD, University of São Paulo; Principal Investigator: Clarice H Park, MD, University of São Paulo

Publications and helpful links

General Publications

• 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, Leao 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 15, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Septic shock; Sepsis; Albumin; Lactated Ringer
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: 360/10