Prevention of Postoperative Acute Kidney Injury (PrevenAKI)

May 30, 2018 updated by: Prof. Dr. Christian Wunder, Wuerzburg University Hospital

Effect of a Kidney Bundle on the Occurence of Postoperative Acute Kidney Injury in Patients at Risk

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wuerzburg, Germany, 97080
        • University Hospital Wuerzburg, Dep. of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Application of the measures of the kidney treatment bundle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative AKI
Time Frame: until day 5 after surgery
AKI according to KDIGO definition
until day 5 after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensive care unit mortality
Time Frame: 28 days and 90 days after surgery
28 days and 90 days after surgery
hospital mortality
Time Frame: up to 100 days after surgery
up to 100 days after surgery
usage of renal replacement therapy (hours)
Time Frame: up to 30 days after surgery
up to 30 days after surgery
length of invasive respirator therapy (hours)
Time Frame: up to 30 days after surgery
up to 30 days after surgery
creatinine in serum
Time Frame: 12 hours, day 2, 3, 5 and 10 after surgery
12 hours, day 2, 3, 5 and 10 after surgery
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
after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery
length of hospital stay
Time Frame: up to 100 days after surgery
up to 100 days after surgery
length of ICU stay
Time Frame: up to 100 days after surgery
up to 100 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Investigators

  • Principal Investigator: Christian Wunder, MD, University of Wuerzburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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