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Completed

NCT Number: NCT06721845

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

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.

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Key information

Conditions

Sepsis Hyperammonemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Menoufia Faculty of Medicine

Shibin Elkoom, Menoufia, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum ammonia specificity and sensitivity in predicting sepsis in comparison to lactate

    Time frame: up to three days.

    Blood samples to obtain Serial ammonia and lactic acid levels

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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