Trial Outcomes & Findings for Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration (NCT NCT02769351)

Last Updated: 2021-08-05

Results Overview

The number of rehospitalizations due to heart failure resp. volume overload has been measured as a clinical endpoint and analyzed based on the AP.

Recruitment status

TERMINATED

Target enrollment

104 participants

Primary outcome timeframe

12 months

Results posted on

2021-08-05

Participant Flow

Out of 104 patients recruited, 46 patients have been included in the safety population (SP; all patients included in analysis), and 44 patients have been included in the analysis population (AP; patients included in analysis with at least one ultrafiltration treatment).

Participant milestones

Participant milestones
Measure	Periph. Minimal Invasive Ultrafiltration Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Overall Study STARTED	46
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Periph. Minimal Invasive Ultrafiltration n=44 Participants Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Age, Continuous	74.71 years STANDARD_DEVIATION 10.76 • n=42 Participants • Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.
Sex: Female, Male Female	14 Participants n=42 Participants • Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.
Sex: Female, Male Male	28 Participants n=42 Participants • Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.
Weight, Continuous	90.19 kg STANDARD_DEVIATION 21.16 • n=42 Participants • Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.
Height, Continuous	171.93 cm STANDARD_DEVIATION 10.30 • n=41 Participants • Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.
Body-Mass-Index (BMI), Continuous	30.03 kg/m^2 STANDARD_DEVIATION 5.10 • n=41 Participants • Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.

PRIMARY outcome

Timeframe: 12 months

Population: The outcome has been analyzed based on the AP (44 patients).

The number of rehospitalizations due to heart failure resp. volume overload has been measured as a clinical endpoint and analyzed based on the AP.

Outcome measures

Outcome measures
Measure	Periph. Minimal Invasive Ultrafiltration n=44 Participants Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Rehospitalisation (Yes/no) Due to Exacerbation of Heart Failure/Volume Overload of Other Origin Rehospitalization due to Heart Failure	7 Rehospitalizations
Rehospitalisation (Yes/no) Due to Exacerbation of Heart Failure/Volume Overload of Other Origin Rehospitalization due to other reasons	12 Rehospitalizations

SECONDARY outcome

Timeframe: Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-9 months); Outpatient visit II ( 12 months)

Population: The outcome has been analyzed on the SP (46 patients). However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per time point.

Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).

Outcome measures

Outcome measures
Measure	Periph. Minimal Invasive Ultrafiltration n=46 Participants Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Significant Deterioration of Kidney Function - Creatinine Creatinine at Recruitment	208.30 mg/L Standard Deviation 71.79
Significant Deterioration of Kidney Function - Creatinine Creatinine at Discharge from Index Hospitalization	180.66 mg/L Standard Deviation 78.13
Significant Deterioration of Kidney Function - Creatinine Creatinine at Outpatient visit I	224.99 mg/L Standard Deviation 162.7
Significant Deterioration of Kidney Function - Creatinine Creatinine at Outpatient visit II	430.31 mg/L Standard Deviation 454.01

SECONDARY outcome

Timeframe: Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-6 months); Outpatient visit II (12 months)

Outcome measures

Outcome measures
Measure	Periph. Minimal Invasive Ultrafiltration n=46 Participants Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Significant Deterioration of Kidney Function - Urea Urea at Recruitment	21.7 mg/dL Standard Deviation 15.01
Significant Deterioration of Kidney Function - Urea Urea at Discharge from Index Hospitalization	51.67 mg/dL Standard Deviation 168.40
Significant Deterioration of Kidney Function - Urea Urea at Outpatient visit I	282.99 mg/dL Standard Deviation 457.51

SECONDARY outcome

Timeframe: Recruitment, Discharge from index hospitalization, Outapteint visit I (3-6 months), Outpatient visit II (12 months)

Outcome measures

Outcome measures
Measure	Periph. Minimal Invasive Ultrafiltration n=46 Participants Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate) eGFR at Recruitment	28.58 mL/min*1.73^2 Standard Deviation 15.56
Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate) eGFR at Discharge from Index hositalization	37.82 mL/min*1.73^2 Standard Deviation 24.48
Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate) eGFR at Outaptient visit I	36.19 mL/min*1.73^2 Standard Deviation 30.87
Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate) eGFR at Outpatient visit II	41.52 mL/min*1.73^2 Standard Deviation 52.96

SECONDARY outcome

Timeframe: recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months), Outpatient visit II (12 months)

Outcome measures

Outcome measures
Measure	Periph. Minimal Invasive Ultrafiltration n=46 Participants Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Significant Deterioration of Kidney Function - Cystatin Cystatin at Recruitment	2.26 mg/mL Standard Deviation 1.72
Significant Deterioration of Kidney Function - Cystatin Cystatin at Discharge from index Hospitalization	0.09 mg/mL Standard Deviation 0.13
Significant Deterioration of Kidney Function - Cystatin Cystatin at Outpatient visit II	6.99 mg/mL

Adverse Events

Periph. Minimal Invasive Ultrafiltration

Serious events: 22 serious events

Other events: 4 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Periph. Minimal Invasive Ultrafiltration n=46 participants at risk Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Cardiac disorders Cardiac failure	19.6% 9/46 • Number of events 10 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Respiratory, thoracic and mediastinal disorders Pneumonia	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Cardiac disorders Cardiac failure chronic	4.3% 2/46 • Number of events 2 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Metabolism and nutrition disorders Fluid retention	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Surgical and medical procedures Hospitalisation	4.3% 2/46 • Number of events 2 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
General disorders Death	8.7% 4/46 • Number of events 4 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Infections and infestations Staphylococcal sepsis	4.3% 2/46 • Number of events 2 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Cardiac disorders Cardiomyopathy	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Surgical and medical procedures Palliative care	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Renal and urinary disorders Chronic kidney disease	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Renal and urinary disorders Acute kidney injury	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Surgical and medical procedures Catheter placement	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Surgical and medical procedures Peritoneal catheter insertion	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Immune system disorders Demyelinating polyneuropathy	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Injury, poisoning and procedural complications Contusion	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155

Other adverse events

Other adverse events
Measure	Periph. Minimal Invasive Ultrafiltration n=46 participants at risk Patients with volume overload receiving ultrafiltration periph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle
Cardiac disorders Atrial fibrillation	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Product Issues Thrombosis in device	2.2% 1/46 • Number of events 1 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155
Surgical and medical procedures Hospitalisation	4.3% 2/46 • Number of events 2 • Adverse events were collected from signing the informed consent up to 12 month after recruitment. Adverse Event Definition has been done according to a form based on ISO 14155

Additional Information

Dr. Jennifer Braun

Fresenius Medical Care Deutschland GmbH

Phone: +49617260893488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60