Trial Outcomes & Findings for Nitrite Infusion in Islet Cell Transplantation (NCT NCT03544242)

Results Overview

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Between the time of induction and the time immediately prior to infusion of either nitrite or saline

Results posted on

2020-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Control: A saline infusion will be administered during the pre-isolation and post-isolation phases.	Pre-Isolation Infusion Pre-Isolation Infusion: A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.	Post-Isolation Infusion Post-Isolation Infusion: A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
Overall Study STARTED	1	1	2
Overall Study COMPLETED	1	1	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitrite Infusion in Islet Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=1 Participants Control: A saline infusion will be administered during the pre-isolation and post-isolation phases.	Pre-Isolation Infusion n=1 Participants Pre-Isolation Infusion: A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.	Post-Isolation Infusion n=2 Participants Post-Isolation Infusion: A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.	Total n=4 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants

PRIMARY outcome

Timeframe: Between the time of induction and the time immediately prior to infusion of either nitrite or saline

Population: The study did not reach sufficient enrollment power for statistical analysis.

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Five minutes prior to the infusion of islet cells

Population: The study did not reach sufficient enrollment power for statistical analysis.

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 20 minutes after the infusion of Islet Cells

Population: The study did not reach sufficient enrollment power for statistical analysis.

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 40 minutes after the infusion of Islet Cells

Population: The study did not reach sufficient enrollment power for statistical analysis.

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 hours post operatively

Population: The study did not reach sufficient enrollment power for statistical analysis.

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hours post operatively

Population: The study did not reach sufficient enrollment power for statistical analysis.

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 72 hours post operatively

Population: The study did not reach sufficient enrollment power for statistical analysis.

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 96 hours post operatively

Population: The study did not reach sufficient enrollment power for statistical analysis.

Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-Isolation Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-Isolation Infusion

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

Adam Sturdivant, MPH

University of Alabama at Birmingham

Phone: 205-934-4042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place