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Lactated Ringer Versus Albumin in Early Sepsis Therapy (RASP)

Primary Purpose

Septic Shock, Severe Sepsis

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Lactated Ringer
Albumin
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Septic shock, Sepsis, Albumin, Lactated Ringer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Lactated Ringer

Albumin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mortality in 7 days for any cause

Secondary Outcome Measures

Evaluation of sequential organ failure assessment (SOFA) score
ICU length of stay
hospital length of stay
ventilator-free days
Needing of renal replacement therapy
days free of vasopressor
Mortality in 28-days

Full Information

First Posted
April 13, 2011
Last Updated
April 3, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01337934
Brief Title
Lactated Ringer Versus Albumin in Early Sepsis Therapy
Acronym
RASP
Official Title
Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Severe Sepsis
Keywords
Septic shock, Sepsis, Albumin, Lactated Ringer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactated Ringer
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Albumin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer
Intervention Description
Lactated Ringer
Intervention Type
Drug
Intervention Name(s)
Albumin
Intervention Description
Albumin 4%
Primary Outcome Measure Information:
Title
Mortality in 7 days for any cause
Time Frame
day 7
Secondary Outcome Measure Information:
Title
Evaluation of sequential organ failure assessment (SOFA) score
Time Frame
from day 1 until day 7 of care in ICU
Title
ICU length of stay
Time Frame
day 28
Title
hospital length of stay
Time Frame
day 28
Title
ventilator-free days
Time Frame
day 28
Title
Needing of renal replacement therapy
Time Frame
day 28
Title
days free of vasopressor
Time Frame
day 28
Title
Mortality in 28-days
Time Frame
28 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliano A Almeida, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ludhmila Hajjar, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Clarice H Park, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo
City
Sao Paulo
State/Province
Sao Paulo/SP
ZIP/Postal Code
01246000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20940381
Citation
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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Lactated Ringer Versus Albumin in Early Sepsis Therapy

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