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

NCT06721845 | Completed

• 1 other identifier: 6/2023, ANET40
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis; hyperammonemia; hyperlactemia; prediction

Outcome Measures

Primary Outcomes (1)

• Serum ammonia specificity and sensitivity in predicting sepsis in comparison to lactate

  Blood samples to obtain Serial ammonia and lactic acid levels

  up to three days.

Study Arms (2)

Group I: Septic patients with positive microbial cultures.

Group II: septic patients with negative microbial culture

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient with sepsis or septic shock

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shibin Elkoom, Menoufia, 32511, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Sepsis; Hyperammonemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of anesthesia, ICU, Pain Management

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 6, 2024
• Study Start: July 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)