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Trial record 25 of 883 for:    Liver Transplant

Intraoperative Glucose Control in Liver Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00780026
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : December 6, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Shawn J. Pelletier, MD, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Liver Transplant
Intervention Drug: insulin
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Strict Glycemic Control Standard of Care Control Total
Hide Arm/Group Description

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
54
(48 to 57)
55
(50.0 to 59.0)
54
(49.0 to 59.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
38
  76.0%
36
  72.0%
74
  74.0%
Male
12
  24.0%
14
  28.0%
26
  26.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  10.0%
4
   8.0%
9
   9.0%
White
41
  82.0%
41
  82.0%
82
  82.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   8.0%
4
   8.0%
8
   8.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
White
41
  82.0%
41
  82.0%
82
  82.0%
African American
5
  10.0%
4
   8.0%
9
   9.0%
Asian
0
   0.0%
1
   2.0%
1
   1.0%
Other
4
   8.0%
4
   8.0%
8
   8.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50
 100.0%
50
 100.0%
100
 100.0%
BMI   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Kg/m2
Number Analyzed 50 participants 50 participants 100 participants
30.4
(25.7 to 35.9)
28.9
(25 to 32.4)
29.6
(25.1 to 34.0)
[1]
Measure Description: The BMI is defined as the body mass (in kilograms) divided by the square of the body height (in meters).
Pre-existing conditions   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Diabetes
13
  26.0%
16
  32.0%
29
  29.0%
Coronary Artery Disease(CAD)
4
   8.0%
4
   8.0%
8
   8.0%
[1]
Measure Description: Preexisting diagnosis for Coronary Artery Disease (CAD)
1.Primary Outcome
Title Infection Rates
Hide Description Number of participants who sustained an infection after surgery
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description:

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Bacterial Infection
27
  54.0%
26
  52.0%
Fungal Infection
11
  22.0%
7
  14.0%
Transplant Incision wound
9
  18.0%
7
  14.0%
Viral
4
   8.0%
6
  12.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.841
Comments P value for Bacterial infection
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.298
Comments P-value for fungal infection
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.585
Comments P value for transplant incision wound
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments P value for viral infection
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With One Year Survival Post Transplant
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description:

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
44
  88.0%
44
  88.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Hospital Length of Stay
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description:

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
Overall Number of Participants Analyzed 50 50
Median (Inter-Quartile Range)
Unit of Measure: days
12.5
(8 to 19)
11
(8 to 19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments If the p-value for the means is > 0.05 between the groups then they will be deemed equivalent.
Statistical Test of Hypothesis P-Value 0.384
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU
Hide Description Requirements for blood transfusion counted as a binary variable yes/no per participant
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description:

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With a Need for Hemodialysis
Hide Description Number of people who had renal failure in the year following liver transplant and needing hemodialysis to support it;
Time Frame 12 months post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description:

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
6
  12.0%
9
  18.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Biliary Complications
Hide Description Number of participants who experienced bile leak or biliary Stricture
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description:

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
bile leak
14
  28.0%
15
  30.0%
Biliary Stricture
13
  26.0%
20
  40.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments P value for bile leak
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments This is the p value for Biliary Stricture
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Venous Thrombotic Complications
Hide Description Number of participants who were diagnosed with portal vein thrombosis post surgery
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description:

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
3
   6.0%
3
   6.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Strict Glycemic Control, Standard of Care Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame All cause mortality and graft loss were followed for 5 years, whereas all other adverse events were followed for 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Strict Glycemic Control Standard of Care Control
Hide Arm/Group Description

strict glycemic control (80 to 110 mg/dl)

insulin: bolus or infusion 80 to 110 mg/dl

standard of care insulin dosing
All-Cause Mortality
Strict Glycemic Control Standard of Care Control
Affected / at Risk (%) Affected / at Risk (%)
Total   12/50 (24.00%)   9/50 (18.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Strict Glycemic Control Standard of Care Control
Affected / at Risk (%) Affected / at Risk (%)
Total   16/50 (32.00%)   11/50 (22.00%) 
Hepatobiliary disorders     
Graft Loss  [1]  16/50 (32.00%)  11/50 (22.00%) 
Death   12/50 (24.00%)  9/50 (18.00%) 
Indicates events were collected by systematic assessment
[1]
Liver
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Strict Glycemic Control Standard of Care Control
Affected / at Risk (%) Affected / at Risk (%)
Total   45/50 (90.00%)   42/50 (84.00%) 
Cardiac disorders     
Major Cardiac Event   4/50 (8.00%)  5/50 (10.00%) 
Hepatobiliary disorders     
Bile Leak   14/50 (28.00%)  15/50 (30.00%) 
Biliary Stricture   13/50 (26.00%)  20/50 (40.00%) 
Infections and infestations     
Infections  [1]  35/50 (70.00%)  32/50 (64.00%) 
Renal and urinary disorders     
Dialysis - renal failure   6/50 (12.00%)  9/50 (18.00%) 
Surgical and medical procedures     
Re-operation for bleeding   10/50 (20.00%)  6/50 (12.00%) 
Re-operation - other   15/50 (30.00%)  9/50 (18.00%) 
Wound dehiscence   12/50 (24.00%)  5/50 (10.00%) 
Vascular disorders     
Portal Vein Thrombosis   3/50 (6.00%)  3/50 (6.00%) 
Indicates events were collected by systematic assessment
[1]
Combination of bacterial, fungal, transplant incision wound or viral infections
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Subramanian Sathishkumar
Organization: University of Michigan
Responsible Party: Shawn J. Pelletier, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT00780026     History of Changes
Other Study ID Numbers: HUM00016106
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: November 3, 2017
Results First Posted: December 6, 2017
Last Update Posted: January 15, 2019