Effect of Preoperative Carbohydrate Loading on Post-operative Insulin Resistance After Donor Hepatectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To compare the insulin resistance by HOMA-IR(Homeostatic model assessment for insulin resistance) on postoperative day 2 between preoperative carbohydrate loading and conventional fasting group after donor hepatectomy.
Study Overview
Brief 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.
Detailed 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-
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Overnight fasting
overnight fasting(minimum 6 hrs) for control group.
Intervention: overnight fasting (Other)
Maltodextrin
Route: Oral Dose:
- 400 ml at 10PM night before surgery(12.5g/100ml)
- 200 ml in the morning at 6 AM (12.5g/100ml) on the day of surgery.
Intervention: Maltodextrine (Dietary Supplement)
Outcomes
Primary Outcomes
To compare the insulin resistance by HOMA-IR(Homeostatic model assessment for insulin resistance) on postoperative day 2 between preoperative carbohydrate loading and conventional fasting group after donor hepatectomy.
Time Frame: Post operative day 2
Secondary Outcomes
- To compare the IL-6 levels after 48 hours of surgery.(48 hours after surgery.)
- To compare the functional recovery by total bilirubin on postoperative day 1(Post operative day 1)
- To compare the functional recovery by total bilirubin on postoperative day 3.(Post operative day 3)
- To compare the functional recovery by PT/INR on postoperative day 3.(Post operative day 3)
- To compare the functional recovery by total bilirubin on postoperative day 5.(Post operative day 5)
- To compare the functional recovery by total bilirubin on postoperative day 14.(Post operative day 14.)
- To compare the C-reactive protein levels after 48 hours of surgery.(48 hours after surgery.)
- To compare the functional recovery by PT/INR on postoperative day 5.(Post operative day 5)
- To compare the functional recovery by PT/INR on postoperative day 7(Post operative day 7)
- To compare the incidence of post operative nausea & vomiting till discharge(1 week after surgery.)
- To compare the functional recovery by PT/INR on postoperative day 1(Post operative day 1)
- To compare the functional recovery by PT/INR on postoperative day 14.(Post operative day 14.)
- To compare the functional recovery by total bilirubin on postoperative day 7(Post operative day 7)
- To compare the IL-6 levels on day 7 after surgery.(On day 7 after surgery.)
- To compare the C-reactive protein levels on day 7 after surgery.(On day 7 after surgery.)
- To compare the length of hospital stay.(2 weeks after surgery)