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


Phase 3
18 Years
N/A
Not Enrolling
Both
Septic Shock, Severe Sepsis

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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

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