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CompletedNCT06721845Updated Dec 6, 2024

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

An observational study in Sepsis, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by Menoufia University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
19 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sepsis

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Keywords

  • sepsis
  • hyperammonemia
  • hyperlactemia
  • prediction
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In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's enrollment of 60 is below the median of 160 across 957 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Menoufia University is the lead sponsor of 197 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patient with sepsis or septic shock

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group I: Septic patients with positive microbial cultures.
  • Group II: septic patients with negative microbial culture
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What researchers measure

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

    Time frame: up to three days.

07

Study locations

1 site
  • Menoufia Faculty of Medicine
    Shibin Elkoom, Menoufia 32511, Egypt
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References and documents

Individual participant data

Plan to share: No — it needs patient and institutional ethical committee approval

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06721845
Responsible party
ashraf magdy eskandr (professor of anesthesia, ICU, Pain Management, Menoufia University) — Principal investigator
First posted
Dec 6, 2024
Start date
Jul 1, 2023
Primary completion
Aug 1, 2024
Completion
Sep 30, 2024
Last update
Dec 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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