Lactated Ringer Versus Albumin in Early Sepsis Therapy

NCT ID: NCT01337934

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-12-31

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.

Conditions

Septic Shock; Severe Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Lactated Ringer

Intervention Type: DRUG

Lactated Ringer

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.

Group Type: ACTIVE_COMPARATOR

Albumin

Intervention Type: DRUG

Albumin 4%

Interventions

Lactated Ringer

Lactated Ringer

Intervention Type: DRUG

Albumin

Albumin 4%

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Juliano P Almeida, MD, PhD

Instituto do Cancer do Estado de Sao Paulo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliano A Almeida, MD

Role: STUDY_CHAIR

University of Sao Paulo

Ludhmila Hajjar, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Clarice H Park, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, Sao Paulo/SP, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 20940381 (View on PubMed)

Other Identifiers

360/10

Identifier Type: -

Identifier Source: org_study_id