Lactated Ringer Versus Albumin in Early Sepsis Therapy (RASP)

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Severe Sepsis; Septic Shock

Treatments: Drug: Lactated Ringer; Drug: Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT01337934

360/10

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

Lactated Ringer

Placebo Comparator group

Description:

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.

Treatment:

Drug: Lactated Ringer

Albumin

Active Comparator group

Description:

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.

Treatment:

Drug: Albumin