Trial Information
Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Mortality in 28 days for any cause
Outcome Time Frame:
day 28
Safety Issue:
No
Principal Investigator
Juliano A Almeida, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Sao Paulo
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
360/10
NCT ID:
NCT01337934
Start Date:
January 2013
Completion Date:
July 2014
Related Keywords:
- Septic Shock
- Severe Sepsis
- Septic shock
- Sepsis
- Albumin
- Lactated Ringer
- Sepsis
- Toxemia
- Shock
- Shock, Septic