NCT04019184

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

July 18, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

July 4, 2019

Last Update Submit

May 20, 2020

Conditions

Cardiac SurgeryAcute Kidney Injury

Keywords

Cardiac surgeryglutamine

Outcome Measures

Primary Outcomes (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.

    12 hours after cardiac surgery

Secondary Outcomes (12)

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

    72 hours after end of cardiac surgery

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

    72 hours after end of cardiac surgery

  • Creatinine Clearance

    one day after cardiac surgery

  • Free-days of vasoactive medications and mechanical ventilation

    28 days after cardiac surgery

  • Renal recovery

    30 days after cardiac surgery

  • +7 more secondary outcomes

Study Arms (2)

Glutamine group

EXPERIMENTAL

Intravenous infusion of 0.5 g/kg body weight (2.5 ml/kg body weight) L-alanyl-Lglutamine over 12 h after randomization

Drug: L-Alanyl/L-Glutamine

Control group

PLACEBO COMPARATOR

Intravenous infusion of 2.5 ml/kg body weight sodium chloride 0.9 % over 12 h after randomization

Drug: Placebo

Interventions

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

Glutamine group
PlaceboDRUG

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

Control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Münster

Münster, 48149, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36730070DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

alanylglutamine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Alexander Zarbock, MD, PhD

    University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 15, 2019

Study Start

July 18, 2019

Primary Completion

February 13, 2020

Study Completion

May 13, 2020

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)