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Cardiac SurgeryPhase 3GlacéNCT04019184

Reduction of Occurence of Acute Kidney Injury (AKI) Through Administration of Glutamine

A Phase 3 study testing L-Alanyl/L-Glutamine in people with Cardiac Surgery and Acute Kidney Injury, run by University Hospital Muenster at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate whether the application of glutamine versus control in patients with high risk for AKI identified by biomarkers can reduce kidney damage after cardiac surgery. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Cardiac Surgery, Acute Kidney Injury
What is being tested?
L-Alanyl/L-Glutamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteGermany
Study dates
18 Jul 2019to 13 May 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients undergoing cardiac surgery with CPB
  • Urinary [TIMP-2]*[IGFBP7] >= 0.3 4h after CPB
  • Written informed consent

Who cannot join

  • Preexisting AKI (stage 1 and higher)
  • Patients with cardiac assist devices
  • Pregnant women, nursing women and women of childbearing potential
  • Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
  • Chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) < 30 ml/min
  • Dialysis dependent CKD
Show all 13Show fewer
  • Prior kidney transplant within the last to 12 months
  • Hypersensitivity to the active substance, or to any of the excipients of the study medication
  • Hepatic insufficiency
  • Severe metabolic acidosis (pH < 7.2)
  • Participation in another intervention trial in the past 3 months
  • Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
  • Persons held in an institution by legal or official order

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Münster

    Münster, 48149

Other trials in Germany

About this study

Official title: Biomarker-guided Implementation of Glutamine to Reduce the Occurence of AKI After Cardiac Surgery

The aim of this study is to evaluate whether the application of glutamine versus control in patients with high risk for AKI identified by biomarkers can reduce kidney damage after cardiac surgery.

Read the detailed description

Cardiac surgery is characterized by an increased production of free radicals as a consequence of surgical trauma, ischemia-reperfusion injury, inflammatory response syndrome in response to the use of the extracorporeal circulation. This results in an increased production and release of free radicals which may lead to an exhaustion of antioxidants and organ failure since the lungs, kidneys, liver and gastrointestinal tract are particularly susceptible to reactive oxidant species. Glutamine is considered as a conditionally indispensable amino acid in catabolic states of critically ill patients. It belongs, together with other mediators, to the host defense as major intracellular direct free radical scavengers. Its depletion has been demonstrated to be an independent predictor of mortality in a group of ICU (intensive care unit) patients. Clinical studies showed a positive outcome effect. In animal models, glutamine reduces the occurrence of AKI after ischemia-reperfusion injury. This could be demonstrated through reduced functional markers as well as reduced renal biomarker levels. Preliminary data suggest that glutamine has pleiotropic effects since it has effects on the immune system (reduced expression of cytokines) as well as on tubular epithelial cells (unpublished animal data from our laboratory).

Thus, a randomized-controlled trial to analyze the effects of glutamine supplementation in high risk patients identified by renal biomarkers undergoing cardiac surgery with cardiopulmonary bypass (CPB) on the effects of kidney damage is urgently needed.

Being tested
L-Alanyl/L-Glutamine, Placebo
Keywords
Cardiac surgery, glutamine
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-Alanyl/L-GlutamineDrug

    Immediately after randomization (not longer than 30 min after fulfilling eligibility criteria), patients will receive intravenous infusions with the investigational drug

  • PlaceboDrug

    Immediately after randomization (not longer than 30 min after fulfilling eligibility criteria), patients will receive intravenous infusions with the placebo

Study groups in NCT04019184
Study groupRoleWhat they receive
Glutamine groupExperimentalIntravenous infusion of 0.5 g/kg body weight (2.5 ml/kg body weight) L-alanyl-Lglutamine over 12 h after randomization
Receives: Drug: L-Alanyl/L-Glutamine
Control groupPlacebo comparatorIntravenous infusion of 2.5 ml/kg body weight sodium chloride 0.9 % over 12 h after randomization
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kidney damage after cardiac surgery identified by measuring biomarkers ([TIMP-2]*[IGFBP7]

    The presence of tissue inhibitor of metalloproteinases (TIMP-2) and insulin-like grwoth-factor binding protein 7 (IGFBP7) in the urine will be measured.

    Measured: 12 hours after cardiac surgery

Secondary outcomes (12)

  1. Occurence of acute kidney injury according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria

    Measured: 72 hours after end of cardiac surgery

  2. Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)

    Definition and classification of acute injury according to the KDIGO (Kidney Disease Improving Global Outcomes) clinical practice guidelines on acute kidney injury

    Measured: 72 hours after end of cardiac surgery

  3. Creatinine Clearance

    Measured: one day after cardiac surgery

  4. Free-days of vasoactive medications and mechanical ventilation

    Measured: 28 days after cardiac surgery

  5. Renal recovery

    Renal recovery is defined as serum creatinine levels < 0.5 mg/dL higher than baseline serum creatinine

    Measured: 30 days after cardiac surgery

  6. Renal recovery

    Renal recovery is defined as serum creatinine levels < 0.5 mg/dL higher than baseline serum creatinine

    Measured: 60 days after cardiac surgery

  7. Renal recovery

    Renal recovery is defined as serum creatinine levels < 0.5 mg/dL higher than baseline serum creatinine

    Measured: 90 days after cardiac surgery

  8. Mortality

    Measured: 30 days after cardiac surgery

  9. Mortality

    Measured: 60 days after cardiac surgery

  10. Mortality

    Measured: 90 days after cardiac surgery

  11. ICU and Hospital stay

    Measured: up to 90 days after cardiac surgery (until discharge)

  12. Number of patients with renal replacement therapy

    Measured: up to 90 days after cardiac surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2019
  2. Study start18 Jul 2019
  3. Primary completion13 Feb 2020
  4. Study completion13 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04019184
Sponsor's protocol ID
UKM17_0035
Other IDs
2018-002832-25, 2018
Acronym
Glacé
Status last verified
May 2020
First submitted
4 Jul 2019
Last updated
21 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weiss R, Meersch M, Gerke M, Wempe C, Schafers M, Kellum JA, Zarbock A. Effect of Glutamine Administration After Cardiac Surgery on Kidney Damage in Patients at High Risk for Acute Kidney Injury: A Randomized Controlled Trial. Anesth Analg. 2023 Nov 1;137(5):1029-1038. doi: 10.1213/ANE.0000000000006288. Epub 2022 Nov 29.

    PubMed 36730070

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing L-Alanyl/L-Glutamine in people with Cardiac Surgery and Acute Kidney Injury, run by University Hospital Muenster at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kidney damage after cardiac surgery identified by measuring biomarkers ([TIMP-2]*[IGFBP7] (time frame: 12 hours after cardiac surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04019184, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.

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