48
Participants
Start Date
June 20, 2018
Primary Completion Date
February 20, 2022
Study Completion Date
March 30, 2022
25% IV albumin
"Intravenous 25% albumin infusion 1.0 g/kg body weight (maximum 100gm) once a week for five weeks for a maximum of 5 infusions. These infusions will be administered over sixty minutes per clinical treatment protocols for this population. Patients and investigators will be blinded as to the characteristic of the infusion. Pre-infusion serum albumin will be checked and if \>4.0gm/dl, then normal saline will be given instead as mentioned in the blinding section above. Samples will be collected before and one hour after the infusion for all patients.~The total grams of albumin infused over the 4 weeks during and outside the study will be collected and compared between groups."
Placebo
"Normal saline infusion 1.0g/kg body weight once a week for five weeks for a maximum of 5 infusions. These infusions will be administered over sixty minutes per clinical treatment protocols for this population. Patients and investigators will be blinded as to the characteristic of the infusion. Pre-infusion serum albumin will be checked and if \>4.0gm/dl, then normal saline will be given instead as mentioned in the blinding section above. Samples will be collected before and one hour after the infusion for all patients.~The total grams of albumin infused over the 4 weeks during and outside the study will be collected and compared between groups."
Hunter Holmes McGuire VA Medical Center, Richmond
Collaborators (1)
McGuire Research Institute
OTHER
Instituto Grifols, S.A.
INDUSTRY
Hunter Holmes Mcguire Veteran Affairs Medical Center
FED