The primary objective of this study is to investigate the effect of the implementation of the KDIGO bundle in patients at high risk for AKI after major surgery as compared to standard of care.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is
- occurrence of moderate or severe AKI according to the KDIGO criteria within 3
days after
major surgery (see 16.2)
Secondary outcome
1. Adherence to the implementation of the KDIGO bundle
2. Occurrence and severity of acute kidney injury within 3 days after major
surgery
3. Change in biomarker values during 12 hours after initial measuring of the
[TIMP-2]*[IGFBP7]
4. Free-days of mechanical organ support through to day 3 .
5. Free-days of vasopressors through day 3
6. Need of RRT at day 30 and 90
7. Duration of RRT at day 30 and 90
8. Renal recovery at day 90
9. 30-day and 90-day mortality
10. ICU length-of-stay and Hospital length-of-stay
11. MAKE90 (major adverse kidney events) at day 90
Background summary
There is no specific therapy for acute kidney injury. It is presumed that
supportive measures improve the care and outcome of patients with acute kidney
injury. The investigators hypothesize that the implementation of a bundle of
supportive measures adapted to patients undergoing major non-cardiac surgery
reduces the occurrence of AKI.
This randomized prospective multicenter trial is needed to investigator whether
the implementation of the bundle of measures is effective to prevent AKI in
high risk patients undergoing major non-cardiac surgery.
Study objective
The primary objective of this study is to investigate the effect of the
implementation of the
KDIGO bundle in patients at high risk for AKI after major surgery as compared
to standard of
care.
Study design
International, multicenter clinical trial
Two arm, randomized, controlled, parallel-group, trial
Intervention
In the intervention group, the recommendations of the KDIGO group (KDIGO
bundle) will be implemented for at least 12 hours, whereas some measures have
to be applied for a longer time period. It should be considered for each
patient what is best for the patient (individualized approach).
The interventions provided are recommendations and not prescriptions. If it is
recommended not use certain medication, less nephrotoxic therapeutic
alternatives should be considered.
The bundle includes:
- discontinuation of nephrotoxic drugs if possible for at least 72 hours after
randomization
- optimization of fluid status and hemodynamic parameters according to a
pre-specified algorithm for the first 12h after randomization
- consideration of a functional hemodynamic monitoring (according to clinical
practice in each center, cardiac output can be measured with several devices)
for 12 hours after randomization
- close monitoring of serum creatinine, fluid balance and urine output (monitor
hourly urine output, serum creatinine and fluid balance every 12 hours) for 72
hours after randomization or until ICU discharge, whatever occurs first
- avoidance of hyperglycemia (>= 150 mg/dl on two consecutive samples more than
3 hours apart) for 72 hours after randomization or until ICU discharge,
whatever occurs first
- consideration of alternatives to radio contrast agents for 72 hours after
randomization, if possible
- discontinuation of ACEi and ARBs during the first 48h after randomization, if
possible
- avoidance of HES, gelatin, and chloride-rich solutions for 72 hours after
randomization
Study burden and risks
No side effects are associated with the implementation of the KDIGO bundle.
None of the patients in both groups will be exposed to additional risks.
Albert-Schweitzer-Campus 1, A1
Muenster 48149
DE
Albert-Schweitzer-Campus 1, A1
Muenster 48149
DE
Listed location countries
Age
Inclusion criteria
1. Patients after major surgery who need to be admitted to the ICU
2. Age > 18 years
3. [TIMP-2]*[IGFBP7] >= 0.3 4-18 hours after surgery
4. Inserted jugular central venous line and a urinary catheter
5. Written informed consent
6. At least one additional risk factor for AKI:
a. Age > 75 years
b. Critical illness such as ongoing requirement of vasopressors or mechanical
ventilation postoperatively
c. Pre- existing chronic kidney disease (eGFR< 60 ml/ min)
d. Intraoperative use of radio contrast agents.
Exclusion criteria
1. Pregnancy or breastfeeding
2. Pre- existing high stages of chronic kidney disease (>=stage 4 i.e. eGFR < 30
ml/ min)
3. Kidney transplant within the last 12 months
4. Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
5. Anuria at inclusion time
6. Preexisting AKI
7. Renal replacement therapy within the last 90 days
8. Indication for renal replacement at the time of inclusion
9. Participation in another interventional trial that investigates a
drug/intervention that affects
the kidney function
10. Persons held in an institution by legal or official order
11. Persons with any kind of dependency on the investigator or employed by the
responsible
institution or investigator
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04647396 |
| CCMO | NL81814.018.22 |