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New study tests if albumin changes can forecast sepsis survival better than current methods.

NCT ID NCT07289906

Diagnosis Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two blood tests—mass change in serum albumin and serum lactic acid—to see which better predicts whether non-surgical ICU patients with sepsis will be discharged or die. Researchers will track 40 adults aged 18-70 with sepsis, excluding those with liver disease or certain kidney conditions. The goal is to find a more reliable way to forecast sepsis prognosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a more accurate tool to predict whether sepsis patients will recover or worsen, helping guide treatment decisions.
What could go wrong
This is a small, early-stage study with only 40 participants, so results may not apply to all patients. The test is not a treatment and will not directly improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

40 people

The number who actually took part.

Started

Sep 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A prospective cohort study is planned, aiming to enroll a minimum of 40 patients. The sample size calculation is based on findings from Mahashabde et al. (2024), which reported that the predictive accuracy of serum lactase for septic shock at admission had an AUC ROC of 0.96, while serum albumin had an AUC ROC of 0.323. The anticipated incidence of septic shock is 42%, as reported in the EPIC ill study (2019). The sample size was calculated to achieve 100% statistical power with a significance level (alpha) of 0.05.

Ages

18 to 70 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged ≥18 year 70 years. Diagnosis of sepsis according to survival sepsis campaign(SSC). Patients admitted for medical (non-surgical) conditions. Exclusion Criteria: * Chronic liver disease or cirrhosis. Hyperalbuminuria (ex: nephrotic syndrome, nephritic syndrome). Terminal illness with an expected survival of less than 24 hours. Refusal or inability to obtain informed consent from patients or their care givers.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prognosis prediction of sepsis in icu patients

Contacts and locations

Locations

  • Hospitals ofAin shams university

    Cairo, Elabasya, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.