Non-Cirrhotic Hyperammonemia Versus Hyperlactatemia in Septic Patients and Impact of Treatment

Completed

• Conditions: Sepsis

• Registration Number: NCT06721845
• Lead Sponsor: Menoufia University

Brief Summary

Objectives: This study aims to determine the validity of hyperammonemia in predicting true sepsis compared to hyperlactemia in critically ill septic patients.

Background: Sepsis is associated with amino acid flux towards the liver, which increases the ammonia load. The combination of decreased clearance and increased load is thought to be the major cause of increased ammonia in sepsis.

Methodology: 60 septic patients were classified into 2 equal groups, Group I: Septic patients with positive microbial cultures. Group II: septic patients with negative cultures enrolled to obtain serum ammonia and lactic acid levels on admission and every six hours for three days. The primary outcome was to detect ammonia specificity and sensitivity in predicting sepsis in comparison to lactate. The secondary outcomes were need for mechanical ventilation, mortality, and length of stay (LHS) within the intensive care unit.

Detailed Description

Objectives: The study compares between non-cirrhotic hyperammonemia and hyperlactemia in predicting sepsis in critically ill septic patients.

The septic patients were classified into 2 equal groups, Group I: Septic patients with positive microbial cultures. Group II: septic patients with negative cultures enrolled to obtain serum ammonia and lactic acid levels on admission and every six hours for three days, to detect ammonia specificity and sensitivity in predicting sepsis in comparison to lactate. also, need for mechanical ventilation, mortality, and length of stay (LHS) within the intensive care unit were reported.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-30
• Study First Submitted: 2024-11-29
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adult patients aged 19-75 years old
• both sexes with severe sepsis and septic shock
• within the first 48 hours of ICU admission

Exclusion Criteria

• Hepatic patients (cirrhotic, hepatitis),
• Renal failure, Ureterosigmoidostomy,
• Malignancy or on Chemotherapy,
• Pregnancy,
• Parenteral nutrition,
• Autoimmune diseases or Immunosuppressive illness, and
• Trauma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum ammonia specificity and sensitivity in predicting sepsis in comparison to lactate	up to three days.	Blood samples to obtain Serial ammonia and lactic acid levels

Trial Locations

Locations (1)

Menoufia Faculty of Medicine; 🇪🇬 Shibin Elkoom, Menoufia, Egypt