Clinical trial NCT01337934: Lactated Ringer Versus Albumin in Early Sepsis Therapy
Official title: Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Septic Shock
Severe Sepsis
Keywords: Septic shock
Sepsis
Albumin
Lactated Ringer
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mortality in 7 days for any cause
timeFrame: day 7
Secondary outcomes:
measure: Evaluation of sequential organ failure assessment (SOFA) score
timeFrame: from day 1 until day 7 of care in ICU
measure: ICU length of stay
timeFrame: day 28
measure: hospital length of stay
timeFrame: day 28
measure: ventilator-free days
timeFrame: day 28
measure: Needing of renal replacement therapy
timeFrame: day 28
measure: days free of vasopressor
timeFrame: day 28
measure: Mortality in 28-days
timeFrame: 28 days after randomization
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo
state: Sao Paulo/SP
Study officials:
affiliation: University of Sao Paulo
name: Juliano A Almeida, MD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Ludhmila Hajjar, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Clarice H Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.