Hyperlactacidemia in Major Abdominal Surgery and Monocarboxylate Receptors

NCT06222021 | Unknown

• 1 other identifier: 5675
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to identify those situations in which the increase of lactate levels is not clinically relevant since it is associated with altered genetic polymorphism of the genes involved in the membrane proteins acting as carriers for lactate (mainly monocarboxylate transporters, MCTs) patients undergoing major abdominal surgery. The main questions it aims to answer are:

1. 1.Is there a relationship between the lactate levels in the immediate post-operative period and the presence of some lactate receptor polymorphisms?
2. 2.Can hyperlactacidemia related to lactate receptor polymorphisms affect length of stay in the recovery room and/or in intensive care unit, postoperative hospital stay, postoperative complications? - Which are the risk factors for hyperlactacidemia in the immediate post-operative period in addition to the presence of lactate receptors polymorphisms?

Conditions

Surgical Procedure, Unspecified; Postoperative Complications; Hyperlactatemia; Abdomen Disease

Outcome Measures

Primary Outcomes (1)

• Lactate levels

  Lactate levels (mmol/L) in the patients carrying the T allele versus the A allele for MCT1 gene.

  3 hours after the end of surgery

Secondary Outcomes (6)

• Polymorphisms of lactate receptors (presence of MCT4 and GPR8)

  Minutes and an average of 30 minutes before the start of surgery

• Lactate clearance

  3 hours after the end of surgery

• Lactate clearance

  24 hours after the end of surgery

• Postoperative recovery

  Hours (RR) or days (ICU) and average of three hours for RR and one day in ICU

• In-hospital stay

  Days until discharge, an average of 7 day

Study Arms (1)

Genetic analysis of polymorphisms of membrane receptors involved in lactate transport

OTHER

Before the start of surgery, after arterial line cannulation, a blood sample will be collected in an ethylenediaminetetraacetic acid (EDTA) test tube for genetic analysis of polymorphisms of membrane receptors involved in lactate transport including transporter family monocarboxylates 1 (MTC1), transporter family monocarboxylates 4 (MTC4) and Gi-coupled protein receptor 81 (GPR81).

Genetic: Genetic analysis of polymorphism of membrane receptors involved in lactate transport

Interventions

Genetic analysis of polymorphism of membrane receptors involved in lactate transport GENETIC

The DNA extracted from the blood samples (through extractor MagCore) will then undergo gene sequencing by Sanger sequencing and/or Custom NGS (Next Generation Sequencing) panels and will be used to identify nucleotide variants within genes involved in lactate transport (MCT-1/4, GPR81).

Genetic analysis of polymorphisms of membrane receptors involved in lactate transport

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Indication for elective major abdominal surgery

You may not qualify if:

• Age \<18 years
• Liver cirrhosis
• Liver surgery
• Intraoperative chemotherapy
• Previous gastric bypass surgery (thiamine deficiency)
• Severe cardiovascular/respiratory impairment
• Mitochondrial diseases
• Pheochromocytoma
• Chronic renal failure ≥ stage III
• Refusal to sign the informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy/Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Postoperative Complications; Hyperlactatemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms

Central Study Contacts

Paola Aceto, MD

CONTACT

00390630154507; paola.aceto@policlinicogemelli.it

Chiara Cambise, MD

CONTACT

00390630154507; chiara.cambise@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will undergo preoperative genomic assay testing

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 24, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 24, 2024

Record last verified: 2023-12

Locations

IT (1)