Trial Outcomes & Findings for The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy (NCT NCT03386435)

Results Overview

The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal aspartate aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

within 7 days after operation

Results posted on

2019-08-19

Participant Flow

For the donor group, adult (aged 18-60 years) liver donors scheduled for elective donor right hepatectomy from August 2016 to July 2017 at Asan Medical Center in Seoul, Korea, were screened for eligibility.

Participant milestones

Participant milestones
Measure	RIPC Group received remote ischemic preconditioning remote ischemic preconditioning: transient brief episodes of ischemia at a remote site before a subsequent prolonged ischemia/reperfusion injury of the target organ	Control Group no intervention
Overall Study STARTED	80	80
Overall Study COMPLETED	75	73
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	RIPC Group received remote ischemic preconditioning remote ischemic preconditioning: transient brief episodes of ischemia at a remote site before a subsequent prolonged ischemia/reperfusion injury of the target organ	Control Group no intervention
Overall Study Protocol Violation	5	7

Baseline Characteristics

The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RIPC n=75 Participants intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started. remote ischemic preconditioning: Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated	Control n=73 Participants In the control group, the same maneuver was applied but without cuff inflation.	Total n=148 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
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	73 Participants n=7 Participants	148 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	51 Participants n=7 Participants	105 Participants n=5 Participants
Race/Ethnicity, Customized Asian	75 Participants n=5 Participants	73 Participants n=7 Participants	148 Participants n=5 Participants
Region of Enrollment South Korea	75 Participants n=5 Participants	73 Participants n=7 Participants	148 Participants n=5 Participants
Body mass index	23.7 kg/m^2 STANDARD_DEVIATION 2.6 • n=5 Participants	24.1 kg/m^2 STANDARD_DEVIATION 2.7 • n=7 Participants	23.9 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: within 7 days after operation

The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal aspartate aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy.

Outcome measures

Outcome measures
Measure	RIPC n=75 Participants intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started. remote ischemic preconditioning: Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated	Control n=73 Participants In the control group, the same maneuver was applied but without cuff inflation.
Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days	145 IU/L Interval 118.5 to 188.0	152 IU/L Interval 129.0 to 180.0

PRIMARY outcome

Timeframe: within 7 days after operation

The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal alanine aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy

Outcome measures

Outcome measures
Measure	RIPC n=75 Participants intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started. remote ischemic preconditioning: Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated	Control n=73 Participants In the control group, the same maneuver was applied but without cuff inflation.
The Maximal Alanine Aminotransferase Level Within 7 Postoperative Days	148 IU/L Interval 120.5 to 197.0	152 IU/L Interval 126.0 to 196.0

SECONDARY outcome

Timeframe: postoperative 7 days

The incidence of delayed recovery of hepatic function (DRHF) were used as surrogate parameters indicating the possible benefits of RIPC. DRHF was defined based on a proposal by the International Study Group of Liver Surgery, as follows: an impaired ability of the liver to maintain its synthetic, excretory, and detoxifying functions, which are characterized by an increased PT INR and concomitant hyperbilirubinemia (considering the normal limits of the local laboratory) on or after postoperative day 5. The normal upper limits of PT and bilirubin in our institutional laboratory were 1.30 INR and 1.2 mg/dL, respectively. If either the PT INR or serum bilirubin concentration was preoperatively elevated, DRHF was defined by an increasing PT INR and increasing serum bilirubin concentration on or after postoperative day 5 (compared with the values of the previous day).

Outcome measures

Outcome measures
Measure	RIPC n=75 Participants intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started. remote ischemic preconditioning: Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated	Control n=73 Participants In the control group, the same maneuver was applied but without cuff inflation.
Number of Participants With Delayed Recovery of Liver Function	5 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

The postoperative liver regeneration index (LRI) at postoperative 1 month ) was used as surrogate parameters indicating the possible benefits of RIPC. The LRI was defined as \[(VLR - VFLR)/VFLR)\] × 100, where VLR is the volume of the liver remnant and VFLR is the volume of the future liver remnant. Liver volume was calculated by CT volumetry using 3-mm-thick dynamic CT images. The graft weight was subtracted from the total liver volume to define the future liver remnant.

Outcome measures

Outcome measures
Measure	RIPC n=75 Participants intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started. remote ischemic preconditioning: Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated	Control n=73 Participants In the control group, the same maneuver was applied but without cuff inflation.
Postoperative Liver Regeneration	83.3 percentage of liver volume Interval 47.7 to 117.7	94.9 percentage of liver volume Interval 61.4 to 131.2

Adverse Events

RIPC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Jun-Gol Song, MD, PhD

Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Phone: +82-2-3010-3869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place