No registrations found.
ID
Source
Brief title
Health condition
Contrast Induced Nephropathy (contrastnefropathie)
CT-pulmonary angiography (CTPA)
Sodium bicarbonate (natriumbicarbonaat)
Prevention (preventie)
Sponsors and support
Address: Leiden University Medical Center, Albinusdreef 2, Postzone C4-70, 2333 ZA Leiden, The Netherlands
email: j.kooiman@lumc.nl
tel: +31 (0)71-526.20.85
Intervention
Outcome measures
Primary outcome
Mean increase in serumcreatinine 2-4 days after CT-PA.
Secondary outcome
1. Increase in serum creatinine > 25% or > 44 umol/l, 3 days (+/- 1 day) after CT-PA with contrast media;
2. Increase in serum creatinine >25% or > 44 umol/l 2 months after CTPA with contrast media or the need for dialysis;
3. Increase in C-cystatine and NGAL 3 days (+/- 1 day) after CT-PA;
4. Increase in NGAL 2 hours after CT-PA.
Background summary
Contrast Induced Nephropathy (CIN) is a decrease in renal function following administration of radiographic contrast agents (defined as an increase in serum creatinine > 25% of > 44 umol). Patients with chronic renal impairment and diabetes are at high risk for CIN. To prevent CIN high risk patients receive hydration prior and post to contrast administration. However, when a patient is suspected of an acute pulmonary embolism (PE) there is no time for a hydration protocol with saline 12 hours prior to CTPA. Since the dosage of contrastmedia nessecary for CTPA is low and the contrastmedia are administered intravenously, the risk for CIN is low and hydration might not be nessecary.
Sodium bicarbonate has proven to be effective in preventing CIN when it is giving 1 hour prior and 6 hours after contrast administration.
The aim of our study is to analyse the mean increase in serum creatinine and the incidence of CIN following CTPA without prehydration compaired to a short prehydration regime with sodium bicarbonate during one hour. Furthermore, the risk of developing CIN after CT-PA with iso-osmolair contrast media is studied for both groups.
Study objective
1. H0= Placebo is inferior to sodium bicarbonate in the prevention of contrast induced nephropathy in patients undergoing CTPA;
2. H1=Placebo is noninferior to sodium bicarbonate in the prevention of contrast induced nephropathy in patients undergoing CTPA.
Study design
1. 2 hours after CTPA;
2. 3 days (+/- 1 day) after CTPA;
3. 2 months after to CTPA when contrast induced nephropathy has been diagnosed.
Intervention
1. Sodium Bicarbonate 1 hour prior to CTPA 1 ml/kg bodyweight;
2. CTPA without any hydration.
Judith Kooiman
Leiden University Medical Center, Albinusdreef 2, Postzone C4-70
Leiden 2333 ZA
The Netherlands
+31 (0)71-526.20.85
j.kooiman@lumc.nl
Judith Kooiman
Leiden University Medical Center, Albinusdreef 2, Postzone C4-70
Leiden 2333 ZA
The Netherlands
+31 (0)71-526.20.85
j.kooiman@lumc.nl
Inclusion criteria
Clinical suspected PE with an indication for CT-PA with intravenous administration of iso-osmolair contrast media and eGFR < 60 ml/min.
Exclusion criteria
1. Age < 18 years;
2. Exposure to contrast media within 7 days;
3. Pregnancy;
4. Allergy to contrastmedia;
5. Systolic bloodpressure < 100 mmHg.
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 |
|---|---|
| NTR-new | NL1847 |
| NTR-old | NTR1958 |
| Other | 2009-013547-11 : EudraCTnumber |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |