Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05293444 |
| Other study ID # |
ILBS-Donor Hepatectomy-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
October 2023 |
| Source |
Institute of Liver and Biliary Sciences, India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It's a randomized control trial to compare the effect of preoperative carbohydrate loading
versus fasting on post operative insulin resistance after donor hepatectomy in terms of donor
outcomes. Investigator will analyze the data and elucidate the value of post operative
insulin resistance in reducing the occurrence of complications, length of hospital stay and
fastening the recovery in donors of Live donor liver transplantation.
Description:
AIM: Investigator aim to study the effect of preoperative carbohydrate loading on insulin
resistance and functional recovery after donor hepatectomy.
(B) Methodology: Present study will be a Randomized Control Trial with randomization into
either study group or control group. Study group will undergo preoperative carbohydrate
loading while control group will have conventional preoperative fasting (minimum 6 hours) in
donors undergoing donor hepatectomy in live donor liver transplantation. Patients will be
allocated to each arm on the basis of block randomization.
400 ml of clear carbohydrate drink (12.5 g/100 ml maltodextrin,50 kcal/100 ml) at 10 PM night
before surgery & 200 ml, 2 hr before induction of anaesthesia will be given to the study
group while overnight fasting(minimum 6 hrs) will be given for control group.
After donor hepatectomy, Insulin resistance will be calculated by HOMA-IR score at 6 AM on
Day of Surgery, 6hrs after surgery, 12 hours and 36 hours (POD 2) after surgery. C-reactive
protein and IL-6 at 6 AM on Day of Surgery, 48 hrs & on day 7 after surgery. Functional
recovery of remnant liver will be assesed by normalization of total bilirubin and PT/INR till
discharge and on day 14 after surgery. Peak lactate levels & time taken for normalization of
lactate will be taken. Incidence of post operative nausea and vomiting and length of hospital
stay will be compared between the two groups
Clinical and demographic parameters to be assessed- Donor-preoperative-Age, sex, BMI, LFTs,
HbA1c, HOMA-IR, IL-6, CRP Operative parameters-duration of surgery, blood loss Postoperative
serial measurements of the following parameters-
HOMA-IR, IL-6, CRP, Lactate level, LFTs, PT-INR, Post operative nausea & vomiting, Day of
discharge These patients would be followed closely in the post-operative period and would be
serially sampled at pre-defined time points for the aforementioned variables. At the end of
the study the incidence of complications as well as improvement in postoperative recovery
will be compared between the 2 groups. The clinical and laboratory parameters will be
compared between those received preoperative carbohydrate loading and overnight fasting
group.
Study Population: Consecutive patients undergoing live donor hepatectomy at ILBS during the
study period.
Study Design:-Randomised Controlled Trial Study Period: December 2021 to May 2023. Inclusion
Criteria All consecutive live liver donors who undergo donor hepatectomy at ILBS Exclusion
criteria Patients refusing to consent for inclusion in the study. Donor hepatectomy for
ALF(acute liver failure) recipient
Sample Size Assuming that HOMA-IR in conventional group is 1.7±0.1 and further investigator
assume that there will be 25% reduction by preoperative carbohydrate loading with α-5%,
Power- 90% and 1:1 ratio. Investigator need to enroll 70 cases i.e, 35 in each group. They
will be randomly allocated in two groups by block randomization method, taking block size as
10 (5 in interventional & conventional group each).
Intervention: In Experimental group the preoperative carbohydrate loading will be done.
The control group will undergo overnight fasting (minimum 6 hrs) preoperatively.
Monitoring and Assessment:
Variables to be measured:
Donor- Preoperative parameters: age, sex, BMI, LFTs, HbA1c, HOMA-IR, IL-6, CRP Operative
parameters: Duration of surgery, blood loss, Postoperative serial measurements of the
following from day one to discharge HOMA-IR, Lactate, IL-6, CRP, LFTs, PT-INR, Post operative
nausea & vomiting,
Day of discharge.
Timing of Sample Collection Group A Preoperative Baseline ( at 6 AM on day of surgery.
Post-Operative:-6 hours after surgery & then daily till discharge. Group B Preoperative
Baseline ( at 6 AM on day of surgery. Post-Operative:-6 hours after surgery & then daily till
discharge. Adverse Effects: None
Statistical Analysis:
Data will be entered in excel worksheet and Statistical analyses will be performed with SPSS
Statistics version 22 (IBM Corp., Armonk, NY). Statistical data will be represented as
frequencies (%) where the continuous variables will be expressed as medians and interquartile
range (IQRs). Continuous variables will be compared with the student t test and Mann-Whitney
test as appropriate. Differences between proportions derived from categorical data will be
compared with Chi-square or Fisher's exact test. Variables will be correlated with clinical
outcomes. Repeated analysis of measures will be applied wherever applicable.
Stopping Rule- In case of significant adverse effects in the experimental arm. (c) EXPECTED
OUTCOME:
1. To establish that preoperative carbohydrate loading will decrease the post operative
insulin resistance and enhances functional recovery after donor hepatectomy.
2. To establish that preoperative carbohydrate loading reduces inflammatory stress
response, incidence of post operative nausea & vomiting and improves the surgical
clinical outcomes.
