Trial Outcomes & Findings for Remote Ischemic Preconditioning Living Donor Renal Transplant Protocol (NCT NCT03084666)

NCT ID: NCT03084666

Last Updated: 2022-05-12

Results Overview

Remote ischemic preconditioning (RIPC) will be accomplished in the treatment group donor and control group donor by inducing intermittent extremity ischemia through intermittent inflation of an extremity tourniquet three times for five-minute intervals with five minutes of deflation between inflation periods. The monitored clinical end points will include total urine output following kidney reperfusion. Magnitude of graft injury is the primary endpoint and will be measured using biochemical markers, such as, plasma and urinary concentration of neutrophil gelatinase associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury molecule-1 (KIM-1). The sample size calculation is based on a projected difference of NGAL levels between the two study arms.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-05-12

Participant Flow

Participant milestones

Measure	Treatment Group Donor The treatment will receive 200 mmHg of pressure from a Zimmer automatic tourniquet system (ATS) for three 5 minute intervals. Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.	Control Group Donor Our control group will receive 20 mmHg of pressure from a Zimmer automatic tourniquet system (ATS) for three 5 minute intervals. Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Remote Ischemic Preconditioning Living Donor Renal Transplant Protocol

Baseline characteristics by cohort

Measure	Treatment Group Donor n=20 Participants The treatment will receive 200 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals. Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.	Control Group Donor n=20 Participants Our control group will receive 20 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals. Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.	Total n=40 Participants Total of all reporting groups
Age, Continuous	45.8 years STANDARD_DEVIATION 10.3 • n=5 Participants	45.7 years STANDARD_DEVIATION 11.0 • n=7 Participants	45.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	4 Participants n=7 Participants	17 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	0 Participants n=7 Participants	0 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	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	18 Participants n=7 Participants	35 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Remote ischemic preconditioning (RIPC) will be accomplished in the treatment group donor and control group donor by inducing intermittent extremity ischemia through intermittent inflation of an extremity tourniquet three times for five-minute intervals with five minutes of deflation between inflation periods. The monitored clinical end points will include total urine output following kidney reperfusion. Magnitude of graft injury is the primary endpoint and will be measured using biochemical markers, such as, plasma and urinary concentration of neutrophil gelatinase associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury molecule-1 (KIM-1). The sample size calculation is based on a projected difference of NGAL levels between the two study arms.

Outcome measures

Measure	Treatment Group Donor n=20 Participants The treatment will receive 200 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals. Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.	Control Group Donor n=20 Participants Our control group will receive 20 mmHg of pressure from a Zimmer ATS tourniquet system for three 5 minute intervals. Zimmer ATS tourniquet system: The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.
Biomarkers Measured to Indicate the Magnitude of Graft Injury Albumin(in pg/ml)	17.5 pg/ml Interval 17.4 to 17.6	17.3 pg/ml Interval 17.2 to 17.8
Biomarkers Measured to Indicate the Magnitude of Graft Injury B2M (in pg/ml)	15.6 pg/ml Interval 14.0 to 16.7	16.1 pg/ml Interval 15.4 to 17.3
Biomarkers Measured to Indicate the Magnitude of Graft Injury Cystatin C (in pg/ml)	14.3 pg/ml Interval 11.6 to 15.5	14.9 pg/ml Interval 14.2 to 15.5
Biomarkers Measured to Indicate the Magnitude of Graft Injury EGF (in pg/ml)	4.7 pg/ml Interval 4.2 to 5.6	5.4 pg/ml Interval 4.8 to 5.8
Biomarkers Measured to Indicate the Magnitude of Graft Injury IGFBP7 (in pg/ml)	8.8 pg/ml Interval 8.4 to 9.2	9.2 pg/ml Interval 8.4 to 9.5
Biomarkers Measured to Indicate the Magnitude of Graft Injury NGAL (in pg/ml)	12.2 pg/ml Interval 11.0 to 14.4	12.9 pg/ml Interval 12.0 to 15.4
Biomarkers Measured to Indicate the Magnitude of Graft Injury OPN (in pg/ml)	11.9 pg/ml Interval 11.2 to 12.1	12.6 pg/ml Interval 11.9 to 13.9
Biomarkers Measured to Indicate the Magnitude of Graft Injury TIMP-2 (in pg/ml)	8.4 pg/ml Interval 6.3 to 9.4	8.1 pg/ml Interval 7.3 to 10.0
Biomarkers Measured to Indicate the Magnitude of Graft Injury Uromodulin (UMOD) (in pg/ml)	12.9 pg/ml Interval 11.8 to 14.3	13.6 pg/ml Interval 12.3 to 14.3

PRIMARY outcome

Timeframe: 6 hours post-operatively

Population: For both groups this outcome was not measured.

RIPC will be accomplished in the treatment group donor and control group donor by inducing intermittent extremity ischemia through intermittent inflation of an extremity tourniquet three times for five-minute intervals with five minutes of deflation between inflation periods. The monitored clinical end points will include total urine output following kidney reperfusion. Magnitude of graft injury is the primary endpoint and will be measured using biochemical markers, such as, plasma and urinary concentration of neutrophil gelatinase associated lipocalin (NGAL), IL-18, and KIM-1. The sample size calculation is based on a projected difference of NGAL levels between the two study arms.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 hours post-operatively

Population: For both groups this outcome was not measured.

RIPC will be accomplished in the treatment group donor and control group donor by inducing intermittent extremity ischemia through intermittent inflation of an extremity tourniquet three times for five-minute intervals with five minutes of deflation between inflation periods. The monitored clinical end points will include total urine output following kidney reperfusion. Magnitude of graft injury is the primary endpoint and will be measured using biochemical markers, such as, plasma and urinary concentration of neutrophil gelatinase associated lipocalin (NGAL), IL-18, and KIM-1. The sample size calculation is based on a projected difference of NGAL levels between the two study arms.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 hours post-operatively

Population: For both groups this outcome was not measured.

RIPC will be accomplished in the treatment group donor and control group donor by inducing intermittent extremity ischemia through intermittent inflation of an extremity tourniquet three times for five-minute intervals with five minutes of deflation between inflation periods. The monitored clinical end points will include total urine output following kidney reperfusion. Magnitude of graft injury is the primary endpoint and will be measured using biochemical markers, such as, plasma and urinary concentration of neutrophil gelatinase associated lipocalin (NGAL), IL-18, and KIM-1. The sample size calculation is based on a projected difference of NGAL levels between the two study arms.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hours post-operatively

Population: For both groups this outcome was not measured.

RIPC will be accomplished in the treatment group donor and control group donor by inducing intermittent extremity ischemia through intermittent inflation of an extremity tourniquet three times for five-minute intervals with five minutes of deflation between inflation periods. The monitored clinical end points will include total urine output following kidney reperfusion. Magnitude of graft injury is the primary endpoint and will be measured using biochemical markers, such as, plasma and urinary concentration of neutrophil gelatinase associated lipocalin (NGAL), IL-18, and KIM-1. The sample size calculation is based on a projected difference of NGAL levels between the two study arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline through 90 days

Population: For both groups this outcome was not measured.

This measure will be a review of those participants that didn't survive this procedure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from baseline through 90 days

Population: For both groups this outcome was not measured.

The number of days will be counted for their ICU stay

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from baseline through 90 days

Population: For both groups this outcome was not measured.

The entire length of hospital stay will be counted in days

Outcome measures

Outcome data not reported

Adverse Events

Treatment Group Donor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group Donor

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

Brant Wagener, MD, PhD

University of Alabama at Birmingham

Phone: 12059346007

Email: bwagener@uabmc.edu

Results disclosure agreements

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