search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Helios Study.


- candidate number8960
- NTR NumberNTR2699
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jan-2011
- Secondary IDsNL33992.058.10 CCMO
- Public TitleHelios Study.
- Scientific TitleSodium bicarbonaat versus Sodium Chloride for the prevention of contrast induced nephropathy following intraarterial contrast administration: A randomised non-inferiority trial.
- ACRONYMHelios Study
- hypothesisA brief sodium bicarbonate infusion of 250 ml 1 our prior to contrast administration is non-inferior to pre and posthydration with a 1000 ml sodium chloride for and after the procedure.
- Healt Condition(s) or Problem(s) studiedContrast Induced Nephropathy , Acute kidney injury
- Inclusion criteria1. eGFR < 60ml/min/1.73m2;
2. In and outpatients.
- Exclusion criteria1. Age < 18 years;
2. Patients with a known allergy for contrast media;
3. Pregnancy;
4. Previous contrast adminisatrions in the last 7 days;
5. No informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-jan-2011
- planned closingdate1-apr-2013
- Target number of participants300
- Interventions1. 250 mL Sodium Bicarbonate 1 hour prior to contrast administration vs.
2. 1000 ml Sodium Chloride prior and after contrast administration.
- Primary outcomeMean increase in serum creatinine 2-4 days after contrast administration.
- Secondary outcome1. Contrast induced nephropathy defined as an increase in serum creatinine > 25% or 44 umol/liter 2-4 days after contrast administration;
2. Chronic loss of renal function after 2 months defined by the definition of contrast induced nephropathy;
3. Contrast induced need for dialysis;
4. Heartfailure due to volume suppletion with an indication for diuretics;
5. Chronic loss of renal function 1 year after contrast administration definined as an increase in serum creatinine > 25% of > 44 Ámol/l,
- Timepoints1. Before contrast adminisatrion;
2. 2-4 days after contrast administration;
3. 2 months after contrast administration;
4. 1 year after contrast administration.
- Trial web sitewww.msbi.nl/helios
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Judith Kooiman
- CONTACT for SCIENTIFIC QUERIES Judith Kooiman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-jan-2011 - 7-apr-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl