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…
ID
Bron
Verkorte titel
Aandoening
Contrast Induced Nephropathy (contrastnefropathie)
CT-pulmonary angiography (CTPA)
Sodium bicarbonate (natriumbicarbonaat)
Prevention (preventie)
Ondersteuning
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Mean increase in serumcreatinine 2-4 days after CT-PA.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
1. Sodium Bicarbonate 1 hour prior to CTPA 1 ml/kg bodyweight;
2. CTPA without any hydration.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Clinical suspected PE with an indication for CT-PA with intravenous administration of iso-osmolair contrast media and eGFR < 60 ml/min.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age < 18 years;
2. Exposure to contrast media within 7 days;
3. Pregnancy;
4. Allergy to contrastmedia;
5. Systolic bloodpressure < 100 mmHg.
Opzet
Deelname
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Register | ID |
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NTR-new | NL1847 |
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