- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Federal
-
Islamabad, Federal, Pakistan, 44000
- Shifa International Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age 18 to 50 years Either gender Scheduled for elective donor hepatectomy
Exclusion Criteria:
- Known metabolic disorders Pre-existing liver dysfunction
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention Group
Participants received a standardized oral carbohydrate drink (maltodextrin solution) 2-4 hours before induction of anaesthesia
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Standardized oral carbohydrate drink (maltodextrin solution) administered 2-4 hours prior to induction of anaesthesia
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Ingen inngripen: Control Group
Participants underwent standard preoperative fasting protocol without carbohydrate loading
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Perioperative Serum Lactate Level
Tidsramme: From induction of anaesthesia through to PACU (approximately 6-8 hours)
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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)
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From induction of anaesthesia through to PACU (approximately 6-8 hours)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
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Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB 479-24
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