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Prevention of Postoperative Acute Kidney Injury (PrevenAKI)

Primary Purpose

Acute Kidney Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
kidney treatment bundle (KDIGO)
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring acute kidney injury, hemodynamic stabilisation, nephrotoxic medication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Wuerzburg, Dep. of Anesthesiology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

kidney treatment bundle (KDIGO)

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of postoperative AKI
AKI according to KDIGO definition

Secondary Outcome Measures

Intensive care unit mortality
hospital mortality
usage of renal replacement therapy (hours)
length of invasive respirator therapy (hours)
creatinine in serum
urine output (total ml)
length of hospital stay
length of ICU stay

Full Information

First Posted
September 23, 2015
Last Updated
May 30, 2018
Sponsor
Wuerzburg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02583945
Brief Title
Prevention of Postoperative Acute Kidney Injury
Acronym
PrevenAKI
Official Title
Effect of a Kidney Bundle on the Occurence of Postoperative Acute Kidney Injury in Patients at Risk
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study medication without approval and stop of financial support
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuerzburg University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
acute kidney injury, hemodynamic stabilisation, nephrotoxic medication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
kidney treatment bundle (KDIGO)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
kidney treatment bundle (KDIGO)
Intervention Description
Application of the measures of the kidney treatment bundle.
Primary Outcome Measure Information:
Title
Incidence of postoperative AKI
Description
AKI according to KDIGO definition
Time Frame
until day 5 after surgery
Secondary Outcome Measure Information:
Title
Intensive care unit mortality
Time Frame
28 days and 90 days after surgery
Title
hospital mortality
Time Frame
up to 100 days after surgery
Title
usage of renal replacement therapy (hours)
Time Frame
up to 30 days after surgery
Title
length of invasive respirator therapy (hours)
Time Frame
up to 30 days after surgery
Title
creatinine in serum
Time Frame
12 hours, day 2, 3, 5 and 10 after surgery
Title
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
Title
length of hospital stay
Time Frame
up to 100 days after surgery
Title
length of ICU stay
Time Frame
up to 100 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Wunder, MD
Organizational Affiliation
University of Wuerzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Wuerzburg, Dep. of Anesthesiology
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

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Prevention of Postoperative Acute Kidney Injury

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