Trial Outcomes & Findings for Intraoperative Glucose Control in Liver Transplant (NCT NCT00780026)

NCT ID: NCT00780026

Last Updated: 2019-01-15

Results Overview

Number of participants who sustained an infection after surgery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2019-01-15

Participant Flow

Participant milestones

Measure	Strict Glycemic Control strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control standard of care insulin dosing
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intraoperative Glucose Control in Liver Transplant

Baseline characteristics by cohort

Measure	Strict Glycemic Control n=50 Participants strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 Participants standard of care insulin dosing	Total n=100 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	55 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	41 Participants n=7 Participants	82 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	41 Participants n=5 Participants	41 Participants n=7 Participants	82 Participants n=5 Participants
Race/Ethnicity, Customized African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
BMI	30.4 kg/m2 n=5 Participants	28.9 kg/m2 n=7 Participants	29.6 kg/m2 n=5 Participants
Pre-existing conditions Diabetes	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Pre-existing conditions Coronary Artery Disease(CAD)	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of participants who sustained an infection after surgery

Outcome measures

Measure	Strict Glycemic Control n=50 Participants strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 Participants standard of care insulin dosing
Infection Rates Bacterial Infection	27 Participants	26 Participants
Infection Rates Fungal Infection	11 Participants	7 Participants
Infection Rates Transplant Incision wound	9 Participants	7 Participants
Infection Rates Viral	4 Participants	6 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Strict Glycemic Control n=50 Participants strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 Participants standard of care insulin dosing
Number of Participants With One Year Survival Post Transplant	44 Participants	44 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Strict Glycemic Control n=50 Participants strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 Participants standard of care insulin dosing
Hospital Length of Stay	12.5 days Interval 8.0 to 19.0	11 days Interval 8.0 to 19.0

SECONDARY outcome

Timeframe: 12 months

Requirements for blood transfusion counted as a binary variable yes/no per participant

Outcome measures

Measure	Strict Glycemic Control n=50 Participants strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 Participants standard of care insulin dosing
Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months post surgery

Number of people who had renal failure in the year following liver transplant and needing hemodialysis to support it;

Outcome measures

Measure	Strict Glycemic Control n=50 Participants strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 Participants standard of care insulin dosing
Number of Participants With a Need for Hemodialysis	6 Participants	9 Participants

SECONDARY outcome

Timeframe: 12 months

Number of participants who experienced bile leak or biliary Stricture

Outcome measures

Measure	Strict Glycemic Control n=50 Participants strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 Participants standard of care insulin dosing
Number of Participants With Biliary Complications bile leak	14 Participants	15 Participants
Number of Participants With Biliary Complications Biliary Stricture	13 Participants	20 Participants

SECONDARY outcome

Timeframe: 12 months

Number of participants who were diagnosed with portal vein thrombosis post surgery

Outcome measures

Measure	Strict Glycemic Control n=50 Participants strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 Participants standard of care insulin dosing
Number of Participants With Venous Thrombotic Complications	3 Participants	3 Participants

Adverse Events

Strict Glycemic Control

Serious events: 16 serious events

Other events: 45 other events

Deaths: 12 deaths

Standard of Care Control

Serious events: 11 serious events

Other events: 42 other events

Deaths: 9 deaths

Serious adverse events

Measure	Strict Glycemic Control n=50 participants at risk strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 participants at risk standard of care insulin dosing
Hepatobiliary disorders Graft Loss	32.0% 16/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	22.0% 11/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Hepatobiliary disorders Death	24.0% 12/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	18.0% 9/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.

Other adverse events

Measure	Strict Glycemic Control n=50 participants at risk strict glycemic control (80 to 110 mg/dl) insulin: bolus or infusion 80 to 110 mg/dl	Standard of Care Control n=50 participants at risk standard of care insulin dosing
Infections and infestations Infections	70.0% 35/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	64.0% 32/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Hepatobiliary disorders Bile Leak	28.0% 14/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	30.0% 15/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Hepatobiliary disorders Biliary Stricture	26.0% 13/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	40.0% 20/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Cardiac disorders Major Cardiac Event	8.0% 4/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	10.0% 5/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Vascular disorders Portal Vein Thrombosis	6.0% 3/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	6.0% 3/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Surgical and medical procedures Re-operation for bleeding	20.0% 10/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	12.0% 6/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Surgical and medical procedures Re-operation - other	30.0% 15/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	18.0% 9/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Renal and urinary disorders Dialysis - renal failure	12.0% 6/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	18.0% 9/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Surgical and medical procedures Wound dehiscence	24.0% 12/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.	10.0% 5/50 • All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.

Additional Information

Subramanian Sathishkumar

University of Michigan

Email: ssatish@med.umich.edu

Results disclosure agreements

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