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| autoid | 95 |
| crg_id | CRG010600031 |
| titleoftrial | Outcome of Acute Renal Failure with different treatment modalities |
| acronymnoftrial | SHARF Treatment Modalities |
| website | http:// |
| identificationno | NCT00322933 |
| leadprefix | Prof |
| leadsurname | Lins |
| leadgivennames | Robert L |
| leadposition | Medical Director |
| leaddepartment | Nephrology Hypertension ZNA Stuivenberg |
| leadorganisation | ZNA Jan Palfijn |
| leadaddress | L. Bremstraat 70, 2170 Antwerpen, Belgium |
| leademail | robert.Lins@pro.tiscali.be |
| leadphone | +32 3 640 20 00 |
| leadfax | +32 3 646 44 79 |
| leadsuffix | |
| contactprefix | Prof |
| contactsurname | Elseviers |
| contactgivennames | Monique M |
| contactposition | Epidemiological Researcher |
| contactdepartment | Faculty of Medicine |
| contactorganisation | University of Antwerp |
| contactaddress | Nieuwe laan 4, 2950 Kapellen |
| contactemail | monique.elseviers@ua.ac.be |
| contactphone | +32 3 664 84 59 |
| contactfax | +32 3 664 84 59 |
| funding | Other |
| otherfunding | WEVENEF vzw [trust raised by the Dept of Nephrology-Hypertension of ZNA Stuivenberg Hospital, Antwerp Belgium] |
| fundingnameofsponsors | WEVENEF vzw |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | April 2002 |
| actualstart | April 2002 |
| proposedcompletiondate | March 2004 |
| actualcompletiondate | March 2004 |
| multi_center_study | yes |
| numberofcentres | 10 |
| multi_national_study | no |
| countrycentres | Belgium |
| researchquestion | To investigate outcome in patients with acute renal failure admitted to the ICU, stratified according to severity of disease (SHARF score) and randomised to different treatment options |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | acute renal failure (serum creatinine > 2 mg/dl) |
| intervention1 | IRRT (intermittent haemodialysis during 4-6 hours daily) |
| intervention2 | CRRT (continuous veno-venous hemofiltration) |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | N/A |
| totalrecruitment | 1600 |
| inclusion | all adult patients (age > 18y)
consecutively admitted to the ICU with a serum creatinine > 2 mg/dl patients were stratifies according disease severity (SHARF score) those in need for RRT were randomized to IRRT or CRRT |
| exclusion | patients with known pre-existing chronic kidney
disease (serum creatinine > 1.5 mg/dl with clearly reduced kidney size on first echography after admission |
| primaryoutcomes | Short-term: hospital mortality, length of stay in
ICU and hospital, renal function at hospital discharge Longterm: mortality after one and two years, renal function, comorbidity (Charlson), quality of life (SF-36), economic impact |
| secondaryoutcomes | Length of stay in ICU and hospital Comorbidity after 1 year (Charlson index) Quality of life after 1 year (SF-36) Cost evaluation during hospitalisation an dfor on eyear after hospital discharge Mortality subgroup analysis for older patients, ventilated patients, patients with sepsis, patients with pre-renal or renal type of ARF |
| reference |
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