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The Compass Trial.

A randomized trial to increase the efficiency of the prevention of contrast induced acute kidney injury. The Compass trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29471
Enrollment
575
Registered
2012-12-21
Start date
2013-02-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contrast induced acute kidney injury (CI-AKI)

Interventions

Randomisation in a 1:1 ratio to: 1. 1 hour prehydration with 250 ml 1.4% sodium bicarbonate
2. No preventive hydration.

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with an eGFR (estimated glomerular filtration rate 30-45 ml/min); 2. Patients with an eGFR 45-60 ml/min and diabetes mellitus (either type 1 or 2); 3. Patients with an eGFR 45-60 ml/min and at least two of the following: Peripheral artery disease, congestive heart failure, age > 75 years, anemia, contrastvolumes > 150 cc or the use of nephrotoxic medication; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. eGFR 20%); 9. Known allergy for iodinated contrast media.

Design outcomes

Primary

MeasureTime frame
Mean relative increase in serum creatinine.

Secondary

MeasureTime frame
1. Incidence of CIN; 2. Recovery of renal function 2 months after CT in patients who developed CIN; 3. Mean relative increase in serum creatinine 7-14 days after contrast administration; 4. Acute kidney injury according to the serum creatinine based RIFLE criteria; 5. The need for dialysis; 6. (Re)hospitalisation, duration of hospitalisation in the two months following randomisation; 7. Visits to the outpatient clinic in the two months following randomisation.

Contacts

Public ContactJudith Kooiman

Leiden University Medical Center, Albinusdreef 2, Postzone C4-70

j.kooiman@lumc.nl+31 (0)71-526.20.85

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)