NCT07723391

Brief Summary

This randomized controlled trial investigated whether preoperative carbohydrate loading reduces perioperative serum lactate levels in patients undergoing donor hepatectomy. Participants were randomized into two groups: an intervention group receiving a standardized oral carbohydrate drink 2-4 hours before surgery, and a control group undergoing standard preoperative fasting. Serum lactate levels were measured at five perioperative time points: induction of anaesthesia, before graft removal, 30 minutes after graft removal, before extubation, and in the post-anaesthesia care unit. The study aimed to determine whether this simple nutritional intervention could improve metabolic preparedness and reduce anaerobic stress in living liver donors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 20, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

Carbohydrate loadingDonor hepatectomySerum lactatePerioperative metabolic optimizationERASLiving donor liver transplantationPreoperative fastingInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • Perioperative Serum Lactate Level

    Serum lactate measured in mmol/L at five perioperative time points: induction of anaesthesia, before graft removal, 30 minutes post graft removal, before extubation, and in the post-anaesthesia care unit (PACU)

    From induction of anaesthesia through to PACU (approximately 6-8 hours)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants received a standardized oral carbohydrate drink (maltodextrin solution) 2-4 hours before induction of anaesthesia

Dietary Supplement: Preoperative Carbohydrate Loading

Control Group

NO INTERVENTION

Participants underwent standard preoperative fasting protocol without carbohydrate loading

Interventions

Standardized oral carbohydrate drink (maltodextrin solution) administered 2-4 hours prior to induction of anaesthesia

Intervention Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 50 years Either gender Scheduled for elective donor hepatectomy

You may not qualify if:

  • Known metabolic disorders Pre-existing liver dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa International Hospital

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (9)

  • Kumar M, Patil NS, Mohapatra N, Yadav A, Sindwani G, Dhingra U, Thomas S, Pamecha V. Preoperative carbohydrate loading reduces perioperative insulin resistance and hastens functional recovery of remnant liver after living donor hepatectomy: An open-label randomized controlled trial. Hepatol Int. 2025 Oct;19(5):1151-1161. doi: 10.1007/s12072-025-10831-5. Epub 2025 May 19.

    PMID: 40389625BACKGROUND
  • Recknagel S, Rademacher S, Hohne C, Lederer AA, Lange UG, Herta T, Seehofer D, Sucher R, Scheuermann U. Prediction of the Postoperative Outcome in Liver Resection Using Perioperative Serum Lactate Levels. J Clin Med. 2023 Mar 7;12(6):2100. doi: 10.3390/jcm12062100.

    PMID: 36983103BACKGROUND
  • Baumgartner R, Engstrand J, Rajala P, Grip J, Ghorbani P, Sparrelid E, Gilg S. Comparing the accuracy of prediction models to detect clinically relevant post-hepatectomy liver failure early after major hepatectomy. Br J Surg. 2024 Jan 3;111(1):znad433. doi: 10.1093/bjs/znad433.

    PMID: 38150185BACKGROUND
  • Zhang Y, Min J. Preoperative Carbohydrate Loading in Gynecological Patients Undergoing Combined Spinal and Epidural Anesthesia. J Invest Surg. 2020 Aug;33(7):587-595. doi: 10.1080/08941939.2018.1546352. Epub 2019 Jan 15.

    PMID: 30644785BACKGROUND
  • Kumar SM, Anandhi A, Sureshkumar S, Keerthi AR, Raja K, Jha AK, Bobby Z, Kate V. Effect of preoperative oral carbohydrate loading on postoperative insulin resistance, patient-perceived well-being, and surgical outcomes in elective colorectal surgery: a randomized controlled trial. J Gastrointest Surg. 2024 Oct;28(10):1654-1660. doi: 10.1016/j.gassur.2024.07.027. Epub 2024 Aug 12.

    PMID: 39142436BACKGROUND
  • Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381.

    PMID: 36629465BACKGROUND
  • Crowley K, Scanaill PO, Hermanides J, Buggy DJ. Current practice in the perioperative management of patients with diabetes mellitus: a narrative review. Br J Anaesth. 2023 Aug;131(2):242-252. doi: 10.1016/j.bja.2023.02.039. Epub 2023 Apr 13.

    PMID: 37061429BACKGROUND
  • Tong E, Chen Y, Ren Y, Zhou Y, Di C, Zhou Y, Shao S, Qiu S, Hong Y, Yang L, Tan X. Effects of preoperative carbohydrate loading on recovery after elective surgery: A systematic review and Bayesian network meta-analysis of randomized controlled trials. Front Nutr. 2022 Nov 23;9:951676. doi: 10.3389/fnut.2022.951676. eCollection 2022.

    PMID: 36505254BACKGROUND
  • Joliat GR, Kobayashi K, Hasegawa K, Thomson JE, Padbury R, Scott M, Brustia R, Scatton O, Tran Cao HS, Vauthey JN, Dincler S, Clavien PA, Wigmore SJ, Demartines N, Melloul E. Guidelines for Perioperative Care for Liver Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations 2022. World J Surg. 2023 Jan;47(1):11-34. doi: 10.1007/s00268-022-06732-5. Epub 2022 Oct 30.

    PMID: 36310325BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mian Usman Hameed

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

December 1, 2024

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations