NDLI: The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery – AIR: study protocol for a randomised controlled trial

Content Provider	Springer Nature : BioMed Central
Author	Statkevicius, Svajunas Bonnevier, Johan Bark, Björn P. Larsson, Erik Öberg, Carl M. Kannisto, Päivi Tingstedt, Bobby Bentzer, Peter
Abstract	Background Administration of fluids to restore normovolaemia is one of the most common therapeutic interventions performed peri-operatively and in the critically ill, but no study has evaluated the importance of infusion rate for the plasma volume-expanding effect of a resuscitation fluid. The present study is designed to test the hypothesis that a slow infusion of resuscitation fluid results in better plasma volume expansion than a rapid infusion. Methods/design The study is a single-centre, assessor-blinded, parallel-group, randomised prospective study. Patients over 40 years of age admitted to the post-operative care unit after a Whipple procedure or major gynaecological surgery and presenting with signs of hypovolaemia are eligible for inclusion. Patients are randomised in a 1:1 fashion with no stratification to either rapid (30 minutes) or slow (180 minutes) infusion of 5% albumin at a dose of 10 ml/kg ideal body weight. Plasma volume is measured using 125I human serum albumin at baseline (prior to albumin infusion) as well as at 30 minutes and 180 minutes after infusion start. The primary endpoint is change in plasma volume from baseline to 180 minutes after the start of 5% albumin infusion. Secondary endpoints include the integral of plasma volume over time from baseline to 180 minutes after the start of the infusion and transcapillary escape rate of albumin (%/h) from 180 minutes to 240 minutes after the start of albumin infusion. In addition, diuresis, change in central venous oxygen saturation, lactate and blood pressure will be evaluated. A total of 70 patients will be included in the study, and the study has 80% power to detect a difference of 4 ml/kg in plasma volume expansion between the two groups. Discussion The present study is the first clinical investigation of the importance of infusion rate for the plasma volume-expanding effect of a resuscitation fluid. Trial registration EudraCT identifier: 2013-004446-42 . Registration date: 20 December 2013. ClinicalTrials.gov identifier: NCT02728921 . Registration date: 31 March 2016.
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-016-1714-5.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-016-1714-5
Journal	Trials
Issue Number	1
Volume Number	17
Language	English
Publisher	BioMed Central
Publisher Date	2016-12-07
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Albumin Infusion rate Plasma volume expansion Permeability Transcapillary escape rate Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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