RASP: Lactated Ringer Versus Albumin in Early Sepsis Therapy

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01337934

Collaborator

(none)

360

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock Severe Sepsis	Drug: Lactated Ringer Drug: Albumin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

Mortality in 7 days for any cause [day 7]

Secondary Outcome Measures

Evaluation of sequential organ failure assessment (SOFA) score [from day 1 until day 7 of care in ICU]
ICU length of stay [day 28]
hospital length of stay [day 28]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo	Sao Paulo	Sao Paulo/SP	Brazil	01246000

Sponsors and Collaborators

University of Sao Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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, 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.

Responsible Party:

Juliano P Almeida, MD, PhD, Instituto do Cancer do Estado de Sao Paulo, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01337934

Other Study ID Numbers:

360/10

First Posted:

Apr 19, 2011

Last Update Posted:

Apr 5, 2018

Last Verified:

Apr 1, 2018

Keywords provided by Juliano P Almeida, MD, PhD, Instituto do Cancer do Estado de Sao Paulo, University of Sao Paulo

Additional relevant MeSH terms:

Sepsis

Shock, Septic

Study Results

No Results Posted as of Apr 5, 2018