UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038949
Receipt No. R000044414
Scientific Title Comparison of postoperative liver function between total intravenous anesthesia and inhalation anesthesia in patients with preoperatively elevated liver transaminase levels: a single-center retrospective cohort study
Date of disclosure of the study information 2019/12/21
Last modified on 2020/06/22 (Ver. 3)

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Basic information
Public title Comparison of postoperative liver function between total intravenous anesthesia and inhalation anesthesia in patients with preoperatively elevated liver transaminase levels: a single-center retrospective cohort study
Acronym Effects of TIVA versus inhalation anesthesia on elevated LFT
Scientific Title Comparison of postoperative liver function between total intravenous anesthesia and inhalation anesthesia in patients with preoperatively elevated liver transaminase levels: a single-center retrospective cohort study
Scientific Title:Acronym Effects of TIVA versus inhalation anesthesia on elevated LFT
Region
Asia(except Japan)

Condition
Condition Patients with preoperatively elevated liver transaminase levels who underwent surgery under general anesthesiaanesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This retrospective study aimed to investigate the effect of total intravenous anesthesia versus inhalation anesthesia on the postoperative liver function in patients with preoperatively elevated liver transaminase levels who underwent surgery under general anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The changes (%, increase or decrease) in liver enzyme (ALT) levels measured within 24 hours before and after surgery
Key secondary outcomes 30-day mortality, length of postoperative hospital stay

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
19 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients that featured elevated preoperative liver enzymes (AST > 40 U/L or ALT > 40 U/L) within 24 hour before operation in non-hepatic surgeries
Key exclusion criteria patients with normal range of preoperative LFT results,
hepatic surgery,heart surgery and Cesarean section
Target sample size 626

Research contact person
Name of lead principal investigator
1st name Byung Gun
Middle name
Last name Lim
Organization Korea University Guro Hospital
Division name Seoul
Zip code 08308
Address 148, Gurodong-ro, Guro-gu, Seoul
TEL 82-2-2626-3231
Email bglim9205@korea.ac.kr

Public contact
Name of contact person
1st name Seok Kyeong
Middle name
Last name Oh
Organization Korea University Guro Hospital
Division name Seoul
Zip code 08308
Address 148, Gurodong-ro, Guro-gu, Seoul
TEL 82-2-2626-1437
Homepage URL
Email nanprayboy@korea.ac.kr

Sponsor
Institute Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Korea University Guro Hospital
Address 148, Gurodong-ro, Guro-gu, Seoul 08308, Korea
Tel +82 2 2626 1635
Email ssessong@korea.ac.kr

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 21 Day

Related information
URL releasing protocol doi: 10.2147/TCRM.S248441
Publication of results Published

Result
URL related to results and publications doi: 10.2147/TCRM.S248441
Number of participants that the trial has enrolled 730
Results 
In 730 patients (TIVA: n=138; INHA: n=592),  postoperative AST and ALT changes were significantly lower in the TIVA group than in the INHA group. After 1:4 propensity score matching (TIVA: n=94; INHA: n=376), only the ALT change was significantly lower after TIVA than after INHA.
Results date posted
2020 Year 06 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
The baseline characteristics were comparable, except for higher comorbidity rates in the TIVA group.
Participant flow 
A total of 12,372 patients was operated under general anesthesia between December 2016 and November 2017. Among these, 11,282 patients with preoperative LFT values within the normal range were excluded. Thereafter, we excluded 29 patients aged <18 years, 109 patients who were undergoing hepatic surgery (n = 61), cardiac surgery (n = 25), and cesarean section (n = 23), 4 patients with neuromuscular disease, and 218 patients whose LFT values were not measured within 24 hrs after surgery. Finally, 730 patients were analyzed in this study.
Adverse events 
Mortality cases of 21 had been identified during the follow-up period of this retrospective study. Among the 21 patients who died, 8 patients died of bleeding; 4 patients, cancer metastasis; 4 patients, sepsis; 3 patients; respiratory failure; and 1 patient, liver cirrhosis aggravation to hepatic encephalopathy.
Outcome measures 
We compared the changes (% increase or decrease) in the liver enzyme levels (ALT and AST) measured within 24 hrs before and after surgery. The liver enzyme level measured at the time closest to the start of the surgery within 24 hrs before surgery was considered the preoperative value, and the level measured at the time closest to the end of the surgery within 24 hrs after surgery was considered the postoperative value.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 04 Month 27 Day
Date of IRB
2017 Year 04 Month 27 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2019 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a retrospective observational study using datasets collected from medical records and clinical database.

Management information
Registered date
2019 Year 12 Month 21 Day
Last modified on
2020 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044414