Trial Outcomes & Findings for High Dose CVVHDF Compared to Standard Dose CVVHDF (NCT NCT00561431)

NCT ID: NCT00561431

Last Updated: 2015-04-14

Results Overview

The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 200 participants
• Primary outcome timeframe: Up to 30 days
• Results posted on: 2015-04-14

Participant Flow

Participant milestones

Measure	Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr	High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Dose CVVHDF Compared to Standard Dose CVVHDF

Baseline characteristics by cohort

Measure	Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) n=100 Participants Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr	High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) n=100 Participants High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants	64 Participants n=7 Participants	121 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants	36 Participants n=7 Participants	79 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 15 • n=5 Participants	58 years STANDARD_DEVIATION 16 • n=7 Participants	60 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	41 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	59 Participants n=7 Participants	116 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Population: Intention to treat

The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.

Outcome measures

Measure	Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) n=100 Participants Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr	High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) n=100 Participants High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)	56 participants	49 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: intention to treat

The number of participants who recover renal function at 30 days after enrollment in each arm.

Outcome measures

Measure	Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) n=100 Participants Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr	High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) n=100 Participants High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT	37 Participants	28 Participants

Adverse Events

Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)

Serious events: 63 serious events

Other events: 0 other events

Deaths: 0 deaths

High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)

Serious events: 72 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) n=100 participants at risk Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr	High Dose Continuous Venovenous Hemodiafiltration (CVVHDF) n=100 participants at risk High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
General disorders death	44.0% 44/100 • Number of events 44 • Time on continuous venovenous hemodiafiltration up to 30 days. The adverse events of death and non renal recovery were not related to the intervention or unexpected. The therapy did not affect this outcome.	51.0% 51/100 • Number of events 51 • Time on continuous venovenous hemodiafiltration up to 30 days. The adverse events of death and non renal recovery were not related to the intervention or unexpected. The therapy did not affect this outcome.
Renal and urinary disorders Renal Failure	63.0% 63/100 • Number of events 63 • Time on continuous venovenous hemodiafiltration up to 30 days. The adverse events of death and non renal recovery were not related to the intervention or unexpected. The therapy did not affect this outcome.	72.0% 72/100 • Number of events 72 • Time on continuous venovenous hemodiafiltration up to 30 days. The adverse events of death and non renal recovery were not related to the intervention or unexpected. The therapy did not affect this outcome.

Other adverse events

Adverse event data not reported

Additional Information

Ashita Tolwani, M.D.

University of Alabama at Birmingham

Phone: 2059752021

Email: atolwani@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place