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Enrollment
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation (Former Sponsor) | UNKNOWN |
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The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | peritoneal dialysis |
|
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extraneal | Drug | Periotneal Dialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Hospitalization (Unadjusted) | 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. | 6 to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Jose | California | United States | ||||
Subjects were required to meet all inclusion and no exclusion criteria for study participation
12 sites were active to enroll subjects from March 2, 2007 through February 29, 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Addition of peritoneal ultrafiltration |
| FG001 | Standard Therapy | Standard therapy for CHF |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Addition of peritoneal ultrafiltration |
| BG001 | Standard Therapy | Standard therapy for CHF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Hospitalization (Unadjusted) | 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. | intent to treat population | Posted | Mean | 95% Confidence Interval | hospitalizations per year | 6 to 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Addition of peritoneal ultrafiltration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
The number of subjects enrolled & duration of therapy were insufficient to complete the planned efficacy analyses & to draw any conclusion regarding all-cause hospitalization rates in both intervention and standard therapy arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global CORP Clinical Trials Disclosure | Vantive | +1 2249484283 | Global.CORP.ClinicalTrialsDisclosure@vantive.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077607 | Icodextrin |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Torrance |
| California |
| United States |
| Denver | Colorado | United States |
| Evanston | Illinois | United States |
| Winston-Salem | North Carolina | United States |
| Melbourne | Victoria | Australia |
| Leuven | Belgium |
| Liège | Belgium |
| Roeselare | Belgium |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Withdrawal by Subject |
|
| Sponsor decision to terminate study |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 6 |
| 6 |
| EG001 | Standard Therapy | Standard therapy for CHF | 4 | 6 |
| fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| diabetic gastroparesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| catheter related complication | General disorders | MedDRA | Systematic Assessment |
|
| fungal peritonitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| shock | Vascular disorders | MedDRA | Systematic Assessment |
|
| jaundice | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| peritonitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
|
| cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| megacolon | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| catheter site pain | General disorders | MedDRA | Systematic Assessment |
|
| asthenia | General disorders | Systematic Assessment |
|
| catheter site erythema | General disorders | Systematic Assessment |
|
| chest pain | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| local swelling | General disorders | Systematic Assessment |
|
| oedema | General disorders | Systematic Assessment |
|
| oedema peripheral | General disorders | Systematic Assessment |
|
| pyrexia | General disorders | Systematic Assessment |
|
| catheter site infection | Infections and infestations | Systematic Assessment |
|
| bronchitis | Infections and infestations | Systematic Assessment |
|
| bursitis infective | Infections and infestations | Systematic Assessment |
|
| escherichia urinary tract infection | Infections and infestations | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| post procedural nausea | Injury, poisoning and procedural complications | Systematic Assessment |
|
| blood glucose increased | Investigations | Systematic Assessment |
|
| international normalized ratio decreased | Investigations | Systematic Assessment |
|
| hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| gout | Metabolism and nutrition disorders | Systematic Assessment |
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| hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hypocholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| lactic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
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| ageusia | Nervous system disorders | Systematic Assessment |
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| myoclonus | Nervous system disorders | Systematic Assessment |
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| tremor | Nervous system disorders | Systematic Assessment |
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| confusional state | Psychiatric disorders | Systematic Assessment |
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| agitation | Psychiatric disorders | Systematic Assessment |
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| anxiety | Psychiatric disorders | Systematic Assessment |
|
| micturition urgency | Renal and urinary disorders | Systematic Assessment |
|
| renal disorder | Renal and urinary disorders | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| haemmorrhage | Vascular disorders | Systematic Assessment |
|
| cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
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| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |