Clinical trial

Hyperlactacidemia in Major Abdominal Surgery: Role of Variation in the Monocarboxylate Receptors

Name
5675
Description
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. Is there a relationship between the lactate levels in the immediate post-operative period and the presence of some lactate receptor polymorphisms? 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? Participants will undergo pre-operative genomic assay testing.
Trial arms
Trial start
2024-02-01
Estimated PCD
2025-08-01
Trial end
2025-10-01
Status
Not yet recruiting
Treatment
Genetic analysis of polymorphism of membrane receptors involved in lactate transport
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).
Arms:
Genetic analysis of polymorphisms of membrane receptors involved in lactate transport
Size
109
Primary endpoint
Lactate levels
3 hours after the end of surgery
Eligibility criteria
Inclusion Criteria: * Age ≥ 18 years * Indication for elective major abdominal surgery Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will undergo preoperative genomic assay testing', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 109, 'type': 'ESTIMATED'}}
Updated at
2024-01-24

1 organization

1 product

5 indications

Indication
Unspecified
Indication
Hyperlactatemia