Trial Outcomes & Findings for Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF) (NCT NCT00288587)

NCT ID: NCT00288587

Last Updated: 2012-06-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: 4 consecutive hours (+/- 30 minutes)
• Results posted on: 2012-06-19

Participant Flow

Participant milestones

Measure	Usual & Customary Care Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.	Ultrafiltration Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Overall Study STARTED	17	19
Overall Study COMPLETED	7	14
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Measure	Usual & Customary Care Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.	Ultrafiltration Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Overall Study Death	4	4
Overall Study Transplant	3	0
Overall Study Adverse Event	1	0
Overall Study Physician Decision	2	0
Overall Study Severe Aortic Stenosis	0	1

Baseline Characteristics

Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)

Baseline characteristics by cohort

Measure	Ultrafiltration n=19 Participants Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.	Usual & Customary Care n=17 Participants Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.	Total n=36 Participants Total of all reporting groups
Age Continuous	60 years STANDARD_DEVIATION 9.1 • n=5 Participants	59 years STANDARD_DEVIATION 15.5 • n=7 Participants	59.5 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants
Glomerular Filtration Rate (GFR) GFR >50 mL/min/1.73m2	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Glomerular Filtration Rate (GFR) GFR <50 mL/min/1.73m2	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 consecutive hours (+/- 30 minutes)

Population: Analysis was performed on the intent-to-treat group which consisted of all patients enrolled in this study.

Outcome measures

Measure	Ultrafiltration n=19 Participants Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.	Usual & Customary Care n=17 Participants Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.	22.0 hours Standard Deviation 4.2	34.8 hours Standard Deviation 6.7

SECONDARY outcome

Timeframe: Time from admission to endpoint achievement

Population: The analysis population was the intent-to-treat group, represented by all patients enrolled in this study.

Outcome measures

Measure	Ultrafiltration n=19 Participants Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.	Usual & Customary Care n=17 Participants Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. Time to discharge from HF unit	3.63 Days Standard Deviation 2.11	3.56 Days Standard Deviation 1.86
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. Time to discharge from hospital	6.98 Days Standard Deviation 4.81	18.93 Days Standard Deviation 18.9

SECONDARY outcome

Timeframe: Intervention start to end.

Population: The analysis population is the intent-to-treat group which includes all patients enrolled on the study.

Outcome measures

Measure	Ultrafiltration n=19 Participants Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.	Usual & Customary Care n=17 Participants Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
Total Volume Removal During the Intervention Period	5215 milliliters Standard Deviation 3406	2167 milliliters Standard Deviation 2380

SECONDARY outcome

Timeframe: Intervention start to end.

Population: The analysis population is the intent-to-treat group which includes all patients enrolled on the study.

Hours of therapy required to remove 1 liter of fluid normalized to body weight.

Outcome measures

Measure	Ultrafiltration n=19 Participants Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.	Usual & Customary Care n=17 Participants Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
Volume Removal Rate.	3.4 milliliters/hour/kilogram Standard Deviation 2.6	0.7 milliliters/hour/kilogram Standard Deviation 1.1

SECONDARY outcome

Timeframe: Hospital discharge to 90 days after discharge

Population: The analysis population is the intent-to-treat group which includes all patients enrolled on the study.

Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.

Outcome measures

Measure	Ultrafiltration n=19 Participants Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.	Usual & Customary Care n=17 Participants Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths	12 participants	10 participants

Adverse Events

Ultrafiltration

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Usual & Customary Care

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ultrafiltration n=19 participants at risk Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.	Usual & Customary Care n=17 participants at risk Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
Cardiac disorders Death (Cardiac reason)	15.8% 3/19 • Number of events 3	23.5% 4/17 • Number of events 4
Infections and infestations Death (Infection-related)	5.3% 1/19 • Number of events 1	0.00% 0/17

Other adverse events

Measure	Ultrafiltration n=19 participants at risk Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.	Usual & Customary Care n=17 participants at risk Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
Cardiac disorders Arrhythmia	5.3% 1/19 • Number of events 1	5.9% 1/17 • Number of events 3
Cardiac disorders Chest Pain	10.5% 2/19 • Number of events 2	0.00% 0/17
Cardiac disorders Brady Arrhythmia	0.00% 0/19	5.9% 1/17 • Number of events 2
Vascular disorders Claudication	5.3% 1/19 • Number of events 1	0.00% 0/17
Gastrointestinal disorders Constipation	15.8% 3/19 • Number of events 3	5.9% 1/17 • Number of events 1
General disorders Cramping	10.5% 2/19 • Number of events 2	0.00% 0/17
Gastrointestinal disorders Diarrhea	0.00% 0/19	5.9% 1/17 • Number of events 1
General disorders Fever > 37.3 C	0.00% 0/19	5.9% 1/17 • Number of events 1
General disorders Headache	10.5% 2/19 • Number of events 2	5.9% 1/17 • Number of events 1
Endocrine disorders Hypoglycemic Episode	5.3% 1/19 • Number of events 1	0.00% 0/17
Renal and urinary disorders Hypotensive Episode	15.8% 3/19 • Number of events 3	23.5% 4/17 • Number of events 4
Infections and infestations Infection	15.8% 3/19 • Number of events 3	11.8% 2/17 • Number of events 2
General disorders Insomnia	10.5% 2/19 • Number of events 2	0.00% 0/17
General disorders Nausea	26.3% 5/19 • Number of events 5	23.5% 4/17 • Number of events 4
General disorders Other	52.6% 10/19 • Number of events 18	41.2% 7/17 • Number of events 11
Vascular disorders Painful Access	0.00% 0/19	5.9% 1/17 • Number of events 1
Cardiac disorders Worsening Heart Failure	10.5% 2/19 • Number of events 2	35.3% 6/17 • Number of events 7
Renal and urinary disorders Worsening Renal Failure	31.6% 6/19 • Number of events 6	23.5% 4/17 • Number of events 4

Additional Information

Leighann Cesar, RN

Cleveland Clinic Foundation

Phone: 216-445-6551

Email: cesar1@ccf.org

Results disclosure agreements

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