- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07723391
Effect of Preoperative Carbohydrate Loading on Serum Lactate Levels in Patients Undergoing Donor Hepatectomy
Effect of Preoperative Carbohydrate Loading on Perioperative Serum Lactate Levels in Patients Undergoing Donor Hepatectomy: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Prolonged preoperative fasting induces peripheral insulin resistance, glycogen depletion, and a catabolic metabolic state that predisposes patients to anaerobic metabolism during major surgery. Donor hepatectomy is a physiologically demanding procedure associated with significant ischaemia-reperfusion stress and an inherent risk of perioperative lactate accumulation.
Preoperative carbohydrate loading has been proposed as a simple nutritional intervention to attenuate fasting-related metabolic stress by preserving glycogen stores and improving insulin sensitivity. However, its specific effect on serum lactate levels in living liver donors undergoing donor hepatectomy remains underexplored.
This prospective randomized controlled trial was conducted at the Department of Anaesthesiology, Shifa International Hospital, Islamabad. Seventy adult patients aged 18-50 years scheduled for elective donor hepatectomy were enrolled and randomized into two equal groups. The intervention group received a standardized oral carbohydrate drink (maltodextrin solution) 2-4 hours before surgery, while the control group underwent standard preoperative fasting. Serum lactate levels were measured at five perioperative time points. Between-group comparisons were performed using the Mann-Whitney U test, and temporal trends were assessed using repeated measures ANOVA.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Federal
-
Islamabad, Federal, Pakistan, 44000
- Shifa International hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 50 years Either gender Scheduled for elective donor hepatectomy
Exclusion Criteria:
- Known metabolic disorders Pre-existing liver dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants received a standardized oral carbohydrate drink (maltodextrin solution) 2-4 hours before induction of anaesthesia
|
Standardized oral carbohydrate drink (maltodextrin solution) administered 2-4 hours prior to induction of anaesthesia
|
|
No Intervention: Control Group
Participants underwent standard preoperative fasting protocol without carbohydrate loading
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perioperative Serum Lactate Level
Time Frame: From induction of anaesthesia through to PACU (approximately 6-8 hours)
|
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)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 479-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Serum Lactate
-
Instituto Mexicano del Seguro SocialCompletedCardiac Surgery | Serum Lactate | Parasternal BlockMexico
-
Istituto Clinico HumanitasEnrolling by invitationSerum Lactate Post-pancreatic DuodenectomyItaly
-
Cairo UniversityCompletedFluid Therapy | Serum Lactate | Intraoperative | Cut-Off Value | Plethysmographic Variability Index | Excision | Supra-Tentorial Brain TumorsEgypt
-
SuperPatch Limited LLCClarity Science LLC; The Altitude Centre; Vichag Healthcare ResearchEnrolling by invitationLactate | VO2max | Lactate ThresholdUnited Kingdom
-
Rabin Medical CenterUnknown
-
National Medical College BirgunjRecruitingAnesthesia | Ringer's LactateNepal
-
University of California, Los AngelesOlive View-UCLA Education & Research InstituteUnknown
-
Imperial College LondonRecruitingExercise | LactateUnited Kingdom
-
Northern State Medical UniversityCompletedCardiosurgery | Continuous Lactate MeasurementsRussian Federation
-
Hualien Tzu Chi General HospitalCompletedCardiopulmonary Bypass | Lactate
Clinical Trials on Preoperative Carbohydrate Loading
-
Eunah Cho, MDCompletedGeneral AnesthesiaKorea, Republic of
-
Medical University of WarsawRecruitingEnd Stage Liver Disease | Liver Transplantation | Liver Transplant | Liver Transplant SurgeryPoland
-
Indonesia UniversityCompleted
-
Tanta UniversityCompletedType 2 Diabetes Mellitus | Gastric Emptying | Postoperative Recovery | Elective Abdominal SurgeryEgypt
-
Aswan University HospitalCompletedCesarean Section ComplicationsEgypt
-
RAK Medical and Health Sciences UniversityRecruitingCardiovascular DiseasesEgypt
-
Armed Police Force Hospital, NepalCompleted
-
Rifdhani Fakhrudin NurCompletedInsulin Resistance | Cardiac SurgeryIndonesia
-
Damascus UniversityRecruitingIschemic Heart Disease | Heart SurgerySyria
-
Medical University of GdanskRecruitingBariatric Surgery | Carbohydrate LoadingPoland