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Phase 3 trial for continuous Kidney replacement therapy (CRRT) for acute Kidney failure subjects

A Multi-center, Randomized, Parallel-group, Active-controlled, Open-label Study of MultiBic® solutions comparative to Prismasol B0®,for Continuous Renal Replacement Therapy (CRRT) for ARF Subjects

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005452
Enrollment
150
Registered
2015-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ACUTE RENAL FAILURE

Interventions

Intervention1: multiBic: MULTIBIC potassium-free Solution for Haemofiltration,MULTIBIC 2 mmol/l potassium Solution for Haemofiltration, MULTIBIC 4 mmol/l potassium Solution for Haemofiltration. MULTIB

Sponsors

FRESENIUS MEDICAL CARE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • ARF subjects aged 18-60 years, 18 and 60 years inclusive. male or female; • Subjects in intensive care unit suffering from acute renal failure and in need or CRRT • Subjects with signed informed consent

Exclusion criteria

Exclusion criteria: • Subjects suffering from chronic renal insufficiency ( serum creatinine > 3mg/dL) • Subjects with serum lactate level > 45mg/dl ( > 5 mmol/L); • Subjects with Blood pH • Pregnant or breastfeeding woman; • Subjects with malignant disease • Subjects participating in another clinical trial • Subjects without written informed consent

Design outcomes

Primary

MeasureTime frame
â?¢ Difference in HCO3- concentration between the 2 groups on treatment day 3Timepoint: â?¢ day 3

Secondary

MeasureTime frame
â?¢ Difference between key electrolytes ( phosphorus, sodium, potassium, Magnesium, Chloride, Calcium) â?¢ Acid base balance (pH) â?¢ Blood glucose â?¢ Recovery of renal function â?¢ Duration of hospital stay â?¢ Mortality rate Timepoint: day 3

Countries

India

Contacts

Public ContactDr Sunil Kumar

Fresenius Medical Care

sunil.k@fmc-asia.com7838333730

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026