Trial Outcomes & Findings for IV Insulin Protocol in Diabetes and Renal Transplantation (NCT NCT00609986)

NCT ID: NCT00609986

Last Updated: 2013-09-06

Results Overview

Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 104 participants
• Primary outcome timeframe: 10 days
• Results posted on: 2013-09-06

Participant Flow

Patients were recruited from the Medical University of South Carolina prior to receiving a renal transplant.

Participant milestones

Measure	Intensive The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Overall Study STARTED	52	52
Overall Study Received Transplant	44	49
Overall Study COMPLETED	44	49
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Measure	Intensive The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Overall Study Did not receive transplant or treatment	8	3

Baseline Characteristics

IV Insulin Protocol in Diabetes and Renal Transplantation

Baseline characteristics by cohort

Measure	Intensive n=44 Participants The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control n=49 Participants The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.	Total n=93 Participants Total of all reporting groups
Age Continuous	58 years STANDARD_DEVIATION 9.8 • n=93 Participants	56.3 years STANDARD_DEVIATION 9.6 • n=4 Participants	57.7 years STANDARD_DEVIATION 9.7 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	35 Participants n=4 Participants	65 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	28 Participants n=93 Participants	28 Participants n=4 Participants	56 Participants n=27 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants	18 Participants n=4 Participants	33 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants

PRIMARY outcome

Timeframe: 10 days

Population: The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.

Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl.

Outcome measures

Measure	Intensive n=44 Participants The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control n=49 Participants The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Delayed Graft Function	8 participants	12 participants

PRIMARY outcome

Timeframe: 30 months

Population: The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.

Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology.

Outcome measures

Measure	Intensive n=44 Participants The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control n=49 Participants The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Acute/Active Rejection	9 participants	2 participants

SECONDARY outcome

Timeframe: 30 months

Population: The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.

Blood glucose less than 40 mg/dl

Outcome measures

Measure	Intensive n=44 Participants The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control n=49 Participants The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Severe Hypoglycemia	7 participants	2 participants

SECONDARY outcome

Timeframe: 30 months

Population: The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.

Blood glucose greater than 350 mg/dl.

Outcome measures

Measure	Intensive n=44 Participants The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control n=49 Participants The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Severe Hyperglycemia	5 participants	12 participants

Adverse Events

Intensive

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intensive n=44 participants at risk The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control n=49 participants at risk The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Renal and urinary disorders renal graft thrombosis	0.00% 0/44	2.0% 1/49 • Number of events 1

Other adverse events

Measure	Intensive n=44 participants at risk The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.	Control n=49 participants at risk The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Endocrine disorders severe hypoglycemia	15.9% 7/44 • Number of events 8	4.1% 2/49 • Number of events 2
Endocrine disorders severe hyperglycemia	11.4% 5/44 • Number of events 5	24.5% 12/49 • Number of events 25

Additional Information

Dr. Kathie Hermayer

Medical University of South Carolina

Phone: 843-792-2529

Email: hermayer@musc.edu

Results disclosure agreements

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