title: The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery - AIR: study protocol for a randomised controlled trial.
abstract: 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.
  
  
  
  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 using125I 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.
  
  
  
  The present study is the first clinical investigation of the importance of infusion rate for the plasma volume-expanding effect of a resuscitation fluid.
  
  
  
  EudraCT identifier: 2013-004446-42 . Registration date: 20 December 2013. ClinicalTrials.gov identifier: NCT02728921 . Registration date: 31 March 2016.
authors.affiliation: Department of Anaesthesia and Intensive Care, Skåne University Hospital, Lund, Sweden.
authors.forename: Svajunas
authors.initials: S
authors.lastname: Statkevicius
authors.affiliation: Department of Anaesthesia and Intensive Care, Skåne University Hospital, Lund, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Bonnevier
authors.affiliation: Department of Anaesthesia and Intensive Care, Skåne University Hospital, Lund, Sweden.
authors.forename: Björn P
authors.initials: BP
authors.lastname: Bark
authors.affiliation: Department of Radiation Physics, Skåne University Hospital, Lund, Sweden.
authors.forename: Erik
authors.initials: E
authors.lastname: Larsson
authors.affiliation: Department of Nephrology, Skåne University Hospital, Lund, Sweden.
authors.forename: Carl M
authors.initials: CM
authors.lastname: Öberg
authors.affiliation: Department of Gynaecology and Obstetrics, Skåne University Hospital, Lund, Sweden.
authors.forename: Päivi
authors.initials: P
authors.lastname: Kannisto
authors.affiliation: Department of Surgery, Skåne University Hospital, Lund, Sweden.
authors.forename: Bobby
authors.initials: B
authors.lastname: Tingstedt
authors.affiliation: Department of Anaesthesia and Intensive Care, Helsingborg Hospital and Lund University, 251 87, Helsingborg, Sweden. peter.bentzer@med.lu.se.
authors.forename: Peter
authors.initials: P
authors.lastname: Bentzer
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000328:Adult; D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D005260:Female; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods*; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects; D006801:Humans; D020896:Hypovolemia / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D007262:Infusions, Intravenous; D008297:Male; D016577:Pancreaticoduodenectomy / Q000009:adverse effects; D010952:Plasma Substitutes / Q000008:administration & dosage* / Q000009:adverse effects; D010953:Plasma Volume; D011446:Prospective Studies; D012107:Research Design; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000418:Albumins; D010952:Plasma Substitutes
keywords: Albumin; Infusion rate; Permeability; Plasma volume expansion; Transcapillary escape rate