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Lactated Ringer Versus Albumin in Early Sepsis Therapy (RASP)

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ClinicalTrials.gov Identifier: NCT01337934
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Juliano P Almeida, MD, PhD, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Septic Shock Severe Sepsis Drug: Lactated Ringer Drug: Albumin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial
Study Start Date : October 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Lactated Ringer
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
Lactated Ringer
Active Comparator: Albumin
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
Albumin 4%



Primary Outcome Measures :
  1. Mortality in 7 days for any cause [ Time Frame: day 7 ]

Secondary Outcome Measures :
  1. Evaluation of sequential organ failure assessment (SOFA) score [ Time Frame: from day 1 until day 7 of care in ICU ]
  2. ICU length of stay [ Time Frame: day 28 ]
  3. hospital length of stay [ Time Frame: day 28 ]
  4. ventilator-free days [ Time Frame: day 28 ]
  5. Needing of renal replacement therapy [ Time Frame: day 28 ]
  6. days free of vasopressor [ Time Frame: day 28 ]
  7. Mortality in 28-days [ Time Frame: 28 days after randomization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337934


Locations
Brazil
Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo
Sao Paulo, Sao Paulo/SP, Brazil, 01246000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Juliano A Almeida, MD University of Sao Paulo
Study Director: Ludhmila Hajjar, PhD University of Sao Paulo
Principal Investigator: Clarice H Park, MD University of Sao Paulo

Publications:
Responsible Party: Juliano P Almeida, MD, PhD, Instituto do Cancer do Estado de Sao Paulo, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01337934     History of Changes
Other Study ID Numbers: 360/10
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Juliano P Almeida, MD, PhD, University of Sao Paulo:
Septic shock
Sepsis
Albumin
Lactated Ringer

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock