Lactated Ringer Versus Albumin in Early Sepsis Therapy (RASP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Juliano P Almeida, MD, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01337934
First received: April 13, 2011
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Septic Shock
Severe Sepsis
Drug: Lactated Ringer
Drug: Albumin
Phase 3

Study Type: 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
Official Title: Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Mortality in 7 days for any cause [ Time Frame: day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of sequential organ failure assessment (SOFA) score [ Time Frame: from day 1 until day 7 of care in ICU ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • hospital length of stay [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • ventilator-free days [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • Needing of renal replacement therapy [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • days free of vasopressor [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • Mortality in 28-days [ Time Frame: 28 days after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 360
Study Start Date: October 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337934

Contacts
Contact: Juliano P Almeida, MD 55-1138933267 doctorjuliano@yahoo.com.br

Locations
Brazil
Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo Recruiting
Sao Paulo, Sao Paulo/SP, Brazil, 01246000
Contact: Julia Fukushima, MsC    55-1138933271    juliafukushima@icesp.org.br   
Principal Investigator: Juliano Almeida, MD         
Sub-Investigator: Julia T Fukushima, MsC         
Sub-Investigator: Rosana E Nakamura, MD         
Sub-Investigator: Filomena RBG Galas, PhD         
Sub-Investigator: Greg Martin, PhD         
Sub-Investigator: Roberto Kalil Filho, PhD         
Sub-Investigator: Danielle Nagaoka, MD         
Sub-Investigator: Felipe Duarte, MD         
Sub-Investigator: Ludhmila Hajjar, PhD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Juliano A Almeida, MD University of Sao Paulo
Study Chair: Greg Martin, PhD Emory University
Study Director: Ludhmila Hajjar, PhD University of Sao Paulo
  More Information

Publications:
Responsible Party: Juliano P Almeida, MD, Principal Investigator, 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
Study First Received: April 13, 2011
Last Updated: October 16, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Septic shock
Sepsis
Albumin
Lactated Ringer

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

ClinicalTrials.gov processed this record on September 16, 2014