Trial Outcomes & Findings for Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients (NCT NCT00998426)
NCT ID: NCT00998426
Last Updated: 2015-09-28
Results Overview
All participants received GNS-POC, GS-POC and venous blood glucose measurements prior to and after HBIG injection( immediately following, 60 and 120 min post dose).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
Pre-dose, immediately following, 60 min and 120 min after injection
Results posted on
2015-09-28
Participant Flow
Adult OLT recipients receiving maintenance HBIG therapy were recruited from the inpatient liver transplant service.
Participant milestones
| Measure |
All Study Participants
Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
Blood Glucose Monitoring
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients
Baseline characteristics by cohort
| Measure |
All Study Participants
n=5 Participants
Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. All participants will undergo two finger stick tests, one with a glucose-specific monitoring device(GS-POC) and one with a glucose non-specific monitoring device(GNS-POC) and a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose ). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
|
adult OLT recipients
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, immediately following, 60 min and 120 min after injectionAll participants received GNS-POC, GS-POC and venous blood glucose measurements prior to and after HBIG injection( immediately following, 60 and 120 min post dose).
Outcome measures
| Measure |
All Study Participants
n=5 Participants
Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.
Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device (GS-POC)and one with a glucose non-specific (GNS-POC) monitoring device; a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring
|
|---|---|
|
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
Pre Dose: GNS POC minus GS POC
|
-3.2 mg/dL
Standard Deviation 8.2
|
|
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
Post Dose GNS POC minus GS POC
|
6.0 mg/dL
Standard Deviation 13.5
|
|
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
60 minutes GNS POC minus GS POC
|
56.6 mg/dL
Standard Deviation 125.1
|
|
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
120 minutes GNS POC minus GS POC
|
-2.6 mg/dL
Standard Deviation 10.1
|
|
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
Predose GNSPOC minus Venous glucose
|
7.4 mg/dL
Standard Deviation 3.5
|
|
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
PredoseGSPOC minus venous blood glucose
|
10.6 mg/dL
Standard Deviation 6
|
|
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
Post-dose GNS POC minus venous blood glucose
|
17 mg/dL
Standard Deviation 12.5
|
|
Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection
Post-dose GS POC minus venous blood glucose
|
11 mg/dL
Standard Deviation 25.7
|
Adverse Events
Acute Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Phase
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place