|- candidate number||6330|
|- NTR Number||NTR1958|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-aug-2009|
|- Secondary IDs||EudraCTnumber 2009-013547-11|
|- Public Title||Sodium Bicarbonate for the prevention of contrast induced nephropathy in patients suspected with acute pulmonary embolism undergoing CTPA.|
|- Scientific Title||Sodium Bicarbonate for the prevention of contrast induced nephropathy in patients suspected with acute pulmonary embolism undergoing CTPA.|
|- ACRONYM||The Nefros Study|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Prevention, Contrast Induced Nephropathy , CT-pulmonary angiography , Sodium bicarbonate |
|- 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;
4. Allergy to contrastmedia;
5. Systolic bloodpressure < 100 mmHg.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||9-jul-2009|
|- planned closingdate||9-jul-2011|
|- Target number of participants||264|
|- Interventions||1. Sodium Bicarbonate 1 hour prior to CTPA 1 ml/kg bodyweight;|
2. CTPA without any hydration.
|- 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.
|- Timepoints||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.
|- Trial web site||in making, probably www.msbi.nl/nefros|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Judith Kooiman|
|- CONTACT for SCIENTIFIC QUERIES|| Judith Kooiman|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||18-aug-2009 - 27-sep-2012|