Trial Outcomes & Findings for Isoflurane Preconditioning for Liver Resections (NCT NCT01031550)

Results Overview

Post operative complications grade IIIB or greater according to Clavien's classification: IIIb=complication necessitating an intervention under general anesthesia; Grade IV=Life threatening complications requiring ICU management, IV a =single organ dysfunction, IVb=multi-organ dysfunction; V=death Suffix d(disability)=subject suffers from complication at time of discharge. This label indicates the need for a follow up to fully evaluate the complication.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

first 7 post operative days

Results posted on

2017-03-20

Participant Flow

Subjects will be randomized in two strata, those with and without preexisting liver disease. Subjects will be screened in pre admission testing

Subjects may withdraw consent

Participant milestones

Participant milestones
Measure	Standard Anesthetic Management standard anesthetic management propofol 100-150mcg/kg/min	Preconditioning With 2 MAC Isoflurane Group preconditioning with isoflurane, anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
Overall Study STARTED	5	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Isoflurane Preconditioning for Liver Resections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Anesthetic Management n=5 Participants standard anesthetic management with propofol 100-150mcg/kg/min	Preconditioning With 2 MAC Isoflurane Group n=3 Participants preconditioning with isoflurane anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Continuous	40 years STANDARD_DEVIATION 10 • n=93 Participants	38 years STANDARD_DEVIATION 8 • n=4 Participants	39 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United States	5 participants n=93 Participants	3 participants n=4 Participants	8 participants n=27 Participants

PRIMARY outcome

Timeframe: first 7 post operative days

Population: Due to termination of the study no data analysis was performed.

Post operative complications grade IIIB or greater according to Clavien's classification: IIIb=complication necessitating an intervention under general anesthesia; Grade IV=Life threatening complications requiring ICU management, IV a =single organ dysfunction, IVb=multi-organ dysfunction; V=death Suffix d(disability)=subject suffers from complication at time of discharge. This label indicates the need for a follow up to fully evaluate the complication.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: first 7 post operative days

Population: Due to termination of the study no data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: first 7 post operative days

Population: Due to termination of the study no data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: first 7 post operative days

Population: Due to termination of the study no data analysis was performed.

Outcome measures

Outcome data not reported

Adverse Events

Standard Anesthetic Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Preconditioning With 2 MAC Isoflurane Group

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

Yuriy Gubenko, MD

UMDNJ

Phone: 973 972-5007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place