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WithdrawnNCT02583945PrevenAKIUpdated Jun 1, 2018

Prevention of Postoperative Acute Kidney Injury

An interventional study of kidney treatment bundle (KDIGO) in Acute Kidney Injury, sponsored by Wuerzburg University Hospital. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-01.

Sponsored by Wuerzburg University Hospital · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Study medication without approval and stop of financial support
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a standardized proceeding in hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI in patients at risk after non-cardiac surgery.

Read the detailed description

All patients included in the study will be treated with the KDIGO-bundle (hemodynamic stabilization, avoidance of nephrotoxic substances, normoglycemia and measurement of creatinine in serum and urine output). 12 h, 24h as well as on day 2, 3, 5 and 10 after admission on ICU the occurence of AKI (according to KDIGO) will be assessed.

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Conditions studied

  • Acute Kidney Injury

Keywords

  • acute kidney injury
  • hemodynamic stabilisation
  • nephrotoxic medication
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In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

Browse Acute Kidney Injury studies →

Lead sponsor

Wuerzburg University Hospital is the lead sponsor of 96 studies on the registry; 18 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age > 65 years
  • chronic kidney disease
  • diabetes mellitus, chronic heart, lung or liver disease
  • hemodynamic instability (intra and/or post-operative)
  • trauma, burn injury, major surgery, usage of x-ray contrast and sepsis.

Exclusion criteria

Exclusion criteria:

  • Age \< 18 years
  • pregnancy
  • kidney graft recipient
  • chronic renal disease with or without renal replacement therapy and cardiac surgery.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    kidney treatment bundle (KDIGO)

    Consequent postoperative application of a kidney treatment bundle: Protocol based hemodynamic optimization and monitoring, regular screening of creatinine in serum and of urine output, no use of potential nephrotoxic medication and normoglycemia.

    Procedure: kidney treatment bundle (KDIGO)

Interventions

  • Procedurekidney treatment bundle (KDIGO)

    Application of the measures of the kidney treatment bundle.

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative AKI

    AKI according to KDIGO definition

    Time frame: until day 5 after surgery

Secondary outcomes

  1. Intensive care unit mortality

    Time frame: 28 days and 90 days after surgery

  2. hospital mortality

    Time frame: up to 100 days after surgery

  3. usage of renal replacement therapy (hours)

    Time frame: up to 30 days after surgery

  4. length of invasive respirator therapy (hours)

    Time frame: up to 30 days after surgery

  5. creatinine in serum

    Time frame: 12 hours, day 2, 3, 5 and 10 after surgery

  6. urine output (total ml)

    Time frame: after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery

  7. length of hospital stay

    Time frame: up to 100 days after surgery

  8. length of ICU stay

    Time frame: up to 100 days after surgery

07

Study locations

1 site
  • University Hospital Wuerzburg, Dep. of Anesthesiology
    Wuerzburg, 97080, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2018, 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
NCT02583945
Lead sponsor
Wuerzburg University Hospital
Responsible party
Prof. Dr. Christian Wunder (Vice chair and leading senior physician, Wuerzburg University Hospital) — Principal investigator
First posted
Oct 22, 2015
Start date
Oct 2015
Primary completion
Oct 2016 (estimated)
Completion
Oct 2017 (estimated)
Last update
Jun 1, 2018

Study contacts

Christian Wunder, MD
principal investigator · University of Wuerzburg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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