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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactated Ringer | Placebo Comparator | 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. |
|
| Albumin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactated Ringer | Drug | Lactated Ringer |
| |
| Albumin |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality in 7 days for any cause | day 7 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliano A Almeida, MD | University of Sao Paulo | Study Chair |
| Ludhmila Hajjar, PhD | University of Sao Paulo | Study Director |
| Clarice H Park, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo | São Paulo | Sao Paulo/SP | 01246000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20940381 | Background | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
Albumin 4% |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |