NCT01337934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
2.5 years until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

April 13, 2011

Last Update Submit

April 3, 2018

Conditions

Septic ShockSevere Sepsis

Keywords

Septic shockSepsisAlbuminLactated Ringer

Outcome Measures

Primary Outcomes (1)

  • Mortality in 7 days for any cause

    day 7

Secondary Outcomes (7)

  • Evaluation of sequential organ failure assessment (SOFA) score

    from day 1 until day 7 of care in ICU

  • ICU length of stay

    day 28

  • hospital length of stay

    day 28

  • ventilator-free days

    day 28

  • Needing of renal replacement therapy

    day 28

  • +2 more secondary outcomes

Study Arms (2)

Lactated Ringer

PLACEBO COMPARATOR

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

Albumin

ACTIVE COMPARATOR

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

Interventions

Lactated RingerDRUG

Lactated Ringer

Lactated Ringer
AlbuminDRUG

Albumin 4%

Albumin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal or higher than 18 years-old
  • Severe sepsis or septic shock into 6 hours of evolution
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, Sao Paulo/SP, 01246000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 20940381BACKGROUND

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

Ringer's LactateAlbumins

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Juliano A Almeida, MD

    University of Sao Paulo

    STUDY CHAIR

  • Ludhmila Hajjar, PhD

    University of Sao Paulo

    STUDY DIRECTOR

  • Clarice H Park, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instituto do Cancer do Estado de Sao Paulo

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 19, 2011

Study Start

October 1, 2013

Primary Completion

October 1, 2016

Study Completion

December 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

BR(1)