Trial Outcomes & Findings for Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver Transplant (NCT NCT00886262)

NCT ID: NCT00886262

Last Updated: 2018-10-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: baseline to 48 hours postop
• Results posted on: 2018-10-17

Participant Flow

Participant milestones

Measure	Vasopressin Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed	Normal Saline Placebo Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
Overall Study STARTED	8	10
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver Transplant

Baseline characteristics by cohort

Measure	Vasopressin n=8 Participants Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed	Normal Saline Placebo n=10 Participants Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants	55.1 years n=7 Participants	56.4 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 48 hours postop

Outcome measures

Measure	Vasopressin n=8 Participants Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed	Normal Saline Placebo n=10 Participants Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
Change in Creatinine Levels	0.5 MG/DL Interval 0.1 to 0.8	0.55 MG/DL Interval 0.1 to 1.3

PRIMARY outcome

Timeframe: 24 hours to 48 hours postop

Outcome measures

Measure	Vasopressin n=8 Participants Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed	Normal Saline Placebo n=10 Participants Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
Change in Urine Output	1353 mL Interval 160.0 to 2830.0	731 mL Interval 10.0 to 1550.0

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Vasopressin n=8 Participants Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed	Normal Saline Placebo n=10 Participants Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
Count of Participants Who Needed Diuretics Postoperatively	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Vasopressin n=8 Participants Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed	Normal Saline Placebo n=10 Participants Normal saline placebo: Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
Count of Patient Who Need Vasopressers in the Perioperative Period	3 Participants	4 Participants

Adverse Events

Vasopressin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Scott Reeves

Medical University of South Carolina

Phone: 843-792-5699

Email: reevess@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place