Clinical Trial: Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of 2 Strategies of Therapeutic Human Serum Albumin Infusion in Critically Ill Patients With Severe Systemic Inflammatory Response Syndrome and Low Plasma Albumin: Continuous Low Versus Inte

Brief Summary:

Primary purpose : mortality at Day 28

Secondary purposes :

  • Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care Unit (ICU)
  • Duration of increasing doses of norepinephrine infusion to maintain target mean arterial pressure
  • Number of care-related infections within ICU

Detailed Summary:

According to currently available literature on therapeutic albumin infusion in critically ill patients, there is room for new approaches to delineate an optimal use of this expansive treatment. Indeed, many authors suggest that the present clinical use of albumin is questionable in critically ill patients as far as changes in morbidity or mortality are concerned and with regards to cost-effectiveness.

It has been reported that protein misfolding and aggregation are a hallmark of several inflammatory diseases. In vitro studies show that very small amounts of albumin are able to restore the physiologic activities of endogenous circulating proteins that had been aggregated in multimeric form during oxidative stress. Recently, the investigators have reported that in vitro albumin restores antimicrobial and anti-inflammatory effects of some chromogranin A-derived peptides. The investigators therefore search to test in vivo, in critically ill patients with severe systemic inflammation requiring norepinephrine infusion, whether therapeutic albumin infused at a low and continuous dosage may modify mortality (primary purpose) and morbidity (secondary purposes) in comparison with intermittent high dosage albumin infusion.


Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: Mortality [ Time Frame: 28 days after inclusion between the two groups ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The length of the circulatory failure requiring albumin infusion [ Time Frame: The estimated period of time will be from date of baseline visit until the date of discharge from the hospital or date of death from any cause, whichever came first, assessed up to 28 days ]

Time from albumin infusion starting to the moment when norepinephrine can be weaned at least by 30% of its peak dose with respect of initial mean arterial pressure target between the two groups.


Original Secondary Outcome: Same as current

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: April 13, 2016
Date Started: September 2016
Date Completion: May 2019
Last Updated: April 25, 2016
Last Verified: April 2016