Lactated Ringer Versus Albumin in Early Sepsis Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Septic Shock, Severe Sepsis

Intervention / Treatment
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* Drug: Lactated Ringer
* Drug: Albumin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lactated Ringer<br>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<br>* Lactated Ringer<br>|
| Active Comparator: Albumin<br>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<br>* Albumin 4%<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septic shock, Sepsis, Albumin, Lactated Ringer