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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Menoufia
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Shibin Elkoom, Menoufia, Egypt, 32511
- Menoufia Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group I: Septic patients with positive microbial cultures.
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Group II: septic patients with negative microbial culture
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Serum ammonia specificity and sensitivity in predicting sepsis in comparison to lactate
Time Frame: up to three days.
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Blood samples to obtain Serial ammonia and lactic acid levels
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up to three days.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6/2023, ANET40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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