Trial Outcomes & Findings for Heart Failure and Peritoneal Ultrafiltration (NCT NCT00368641)
NCT ID: NCT00368641
Last Updated: 2025-07-15
Results Overview
All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
6 to 24 months
Results posted on
2025-07-15
Participant Flow
12 sites were active to enroll subjects from March 2, 2007 through February 29, 2008
Subjects were required to meet all inclusion and no exclusion criteria for study participation
Participant milestones
| Measure |
Intervention Group
Addition of peritoneal ultrafiltration
|
Standard Therapy
Standard therapy for CHF
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Intervention Group
Addition of peritoneal ultrafiltration
|
Standard Therapy
Standard therapy for CHF
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Sponsor decision to terminate study
|
2
|
5
|
Baseline Characteristics
Heart Failure and Peritoneal Ultrafiltration
Baseline characteristics by cohort
| Measure |
Intervention Group
n=6 Participants
Addition of peritoneal ultrafiltration
|
Standard Therapy
n=6 Participants
Standard therapy for CHF
|
Total
n=12 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
77.8 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
74.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4.0 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6.0 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 to 24 monthsPopulation: intent to treat population
All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.
Outcome measures
| Measure |
Intervention Group
n=6 Participants
Addition of peritoneal ultrafiltration
|
Standard Therapy
n=6 Participants
Standard therapy for CHF
|
|---|---|---|
|
All-cause Hospitalization (Unadjusted)
|
5.33 hospitalizations per year
Interval 3.13 to 9.05
|
1.69 hospitalizations per year
Interval 0.95 to 2.99
|
Adverse Events
Intervention Group
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard Therapy
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Group
Addition of peritoneal ultrafiltration
|
Standard Therapy
Standard therapy for CHF
|
|---|---|---|
|
Infections and infestations
pneumonia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
fluid overload
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
chronic myeloid leukaemia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
cellulitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
cardiac failure congestive
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
diabetic gastroparesis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
catheter related complication
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Infections and infestations
fungal peritonitis
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Renal and urinary disorders
renal failure acute
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
shock
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Hepatobiliary disorders
jaundice
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
peritonitis bacterial
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
|
Cardiac disorders
cardiac arrest
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
peritonitis
|
20.0%
1/5 • Number of events 1
|
—
0/0
|
Other adverse events
| Measure |
Intervention Group
Addition of peritoneal ultrafiltration
|
Standard Therapy
Standard therapy for CHF
|
|---|---|---|
|
General disorders
oedema
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
oedema peripheral
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
pyrexia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
catheter site infection
|
33.3%
2/6 • Number of events 2
|
—
0/0
|
|
Infections and infestations
bronchitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
bursitis infective
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
escherichia urinary tract infection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
respiratory tract infection
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
upper respiratory tract infection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
contusion
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
excoriation
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
fall
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
post procedural nausea
|
16.7%
1/6 • Number of events 1
|
—
0/0
|
|
Investigations
blood glucose increased
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
international normalized ratio decreased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypokalaemia
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
fluid overload
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
anorexia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
gout
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hyperlipidaemia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperuricaemia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypocholesterolaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hyponatraemia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
lactic acidosis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
dizziness
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Nervous system disorders
ageusia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
myoclonus
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
tremor
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
confusional state
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Psychiatric disorders
agitation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
anxiety
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
micturition urgency
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
renal disorder
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnoea syndrome
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
haemmorrhage
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
cardiac failure
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
anaemia
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
cardiac failure congestive
|
50.0%
3/6 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
nausea
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
megacolon
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
catheter site pain
|
50.0%
3/6 • Number of events 3
|
—
0/0
|
|
General disorders
asthenia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
catheter site erythema
|
16.7%
1/6 • Number of events 1
|
—
0/0
|
|
General disorders
chest pain
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
fatigue
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
local swelling
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place