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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06721845

Enrollment

Registered

2024-12-06

Start date

2023-07-01

Completion date

2024-09-30

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, hyperammonemia, hyperlactemia, prediction

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results