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Antioxidants may shield kidneys from colistin damage in ICU patients

NCT ID NCT06650384

Prevention 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed trial tested whether two antioxidants, N-acetylcysteine and alpha-lipoic acid, could prevent kidney damage caused by the antibiotic colistin in 180 critically ill patients. Participants received either colistin alone or colistin plus one of the antioxidants. The study tracked kidney function daily to see if the antioxidants reduced the risk of acute kidney injury.

What this could mean

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

Active substance
N-acetylcysteine and alpha-lipoic acid
What this could lead to
If successful, this could point toward a simple way to protect kidneys in critically ill patients who need colistin, reducing the risk of kidney failure.
What could go wrong
This is a completed Phase 2/3 trial, but results are not yet widely confirmed. The benefit may be small or not apply to all patients, and antioxidants can have side effects.

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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

180 people

The number who actually took part.

Started

Nov 2024

Finished

Feb 2026

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Adult patients ≥ 18 years 2. Critically ill patients initiating treatment with colistin for suspected or confirmed multi-drug-resistant Gram-negative bacterial infection as per culture Exclusion Criteria: 1. Patient is in AKI according to KDIGO guidelines in 2012 KDIGO.org. Accessed at 17/2/2024) 2. Any kidney disorder including (glomerulonephritis, polycystic kidney disease, kidney stones, interstitial nephritis, renal artery stenosis and renal carcinoma). 3. Known allergy to colistin, N-acetylcysteine or alpha-lipoic acid 4. Patients with factors requiring NPO (nothing per oral)

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As listed by the trial registrant

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

Nephrotoxicity

Contacts and locations

Locations

  • Critical Care Medicine Department,Cairo University Hospitals

    Cairo, Egypt

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