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Acute Renal Failure Trial Network (ATN) Study (ATN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00076219
Recruitment Status : Completed
First Posted : January 19, 2004
Results First Posted : August 16, 2013
Last Update Posted : August 23, 2013
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Renal Failure
Intervention Procedure: renal replacement therapy
Enrollment 1124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive Renal Replacement Therapy Less-intensive Renal Replacement Therapy
Hide Arm/Group Description In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour. In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
Period Title: Overall Study
Started 563 561
Completed 545 550
Not Completed 18 11
Arm/Group Title Intensive Renal Replacement Therapy Less-intensive Renal Replacement Therapy Total
Hide Arm/Group Description In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour. In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour. Total of all reporting groups
Overall Number of Baseline Participants 563 561 1124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 563 participants 561 participants 1124 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
341
  60.6%
335
  59.7%
676
  60.1%
>=65 years
222
  39.4%
226
  40.3%
448
  39.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 563 participants 561 participants 1124 participants
59.6  (15.3) 59.7  (15.2) 59.7  (15.3)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 563 participants 561 participants 1124 participants
Female 154 176 330
Male 409 384 793
[1]
Measure Description: One subject has missing gender.
1.Primary Outcome
Title 60-day All-cause Mortality
Hide Description 60-day all-cause mortality
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of all-cause mortality by day 60
Arm/Group Title Intensive Renal Replacement Therapy Less-intensive Renal Replacement Therapy
Hide Arm/Group Description:
In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
Overall Number of Participants Analyzed 563 561
Measure Type: Number
Unit of Measure: participants
302 289
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Renal Replacement Therapy, Less-intensive Renal Replacement Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.86 to 1.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensive Renal Replacement Therapy Less-intensive Renal Replacement Therapy
Hide Arm/Group Description In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour. In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
All-Cause Mortality
Intensive Renal Replacement Therapy Less-intensive Renal Replacement Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Intensive Renal Replacement Therapy Less-intensive Renal Replacement Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   287/563 (50.98%)      280/561 (49.91%)    
Blood and lymphatic system disorders     
Coagulopathy  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Disseminated intravascular coagulation  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Histiocytosis haematophagic  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Atrial fibrillation  1  8/563 (1.42%)  9 9/561 (1.60%)  9
Atrial flutter  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Atrial thrombosis  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Bradycardia  1  2/563 (0.36%)  2 2/561 (0.36%)  2
Cardiac aneurysm  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Cardiac arrest  1  2/563 (0.36%)  2 2/561 (0.36%)  2
Cardiac failure  1  2/563 (0.36%)  2 2/561 (0.36%)  2
Cardiac failure congestive  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Cardiac tamponade  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Cardio-respiratory arrest  1  2/563 (0.36%)  2 5/561 (0.89%)  5
Cardiogenic shock  1  3/563 (0.53%)  3 1/561 (0.18%)  1
Cardiomegaly  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Cardiomyopathy  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Cardiopulmonary failure  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Coronary artery disease  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Electromechanical dissociation  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Left ventricular failure  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Mitral valve disease  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Myocardial infarction  1  2/563 (0.36%)  2 9/561 (1.60%)  9
Pericardial rub  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Rhythm idioventricular  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Sinus bradycardia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Tachycardia  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Ventricular extrasystoles  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Ventricular failure  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Ventricular fibrillation  1  1/563 (0.18%)  1 2/561 (0.36%)  2
Ventricular tachycardia  1  3/563 (0.53%)  3 6/561 (1.07%)  8
Congenital, familial and genetic disorders     
Sickle cell anaemia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Sickle cell anaemia with crisis  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  3/563 (0.53%)  4 3/561 (0.53%)  3
Gastrointestinal necrosis  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Haematochezia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Intestinal infarction  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Intestinal ischaemia  1  7/563 (1.24%)  7 1/561 (0.18%)  1
Intestinal perforation  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Large intestine perforation  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Oesophageal haemorrhage  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Oesophageal varices haemorrhage  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Pancreatitis  1  0/563 (0.00%)  0 2/561 (0.36%)  2
Peritoneal haemorrhage  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Retroperitoneal haematoma  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Retroperitoneal haemorrhage  1  1/563 (0.18%)  1 1/561 (0.18%)  1
General disorders     
Adverse drug reaction  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Catheter site haemorrhage  1  3/563 (0.53%)  3 4/561 (0.71%)  4
Chest pain  1  0/563 (0.00%)  0 2/561 (0.36%)  3
Death  1  6/563 (1.07%)  6 2/561 (0.36%)  2
Multi-organ failure  1  40/563 (7.10%)  40 46/561 (8.20%)  48
Hepatobiliary disorders     
Alcoholic liver disease  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Hepatic failure  1  9/563 (1.60%)  9 5/561 (0.89%)  5
Hepatitis  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Hepatitis alcoholic  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Liver disorder  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Immune system disorders     
Graft versus host disease  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Heart transplant rejection  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Lung transplant rejection  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Infections and infestations     
Abdominal infection  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Bacteraemia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Bacterial sepsis  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Catheter related infection  1  3/563 (0.53%)  3 2/561 (0.36%)  2
Catheter site infection  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Empyema  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Endocarditis  1  3/563 (0.53%)  3 1/561 (0.18%)  1
Endocarditis staphylococcal  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Enterococcal bacteraemia  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Fungaemia  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Fungal infection  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Fungal sepsis  1  2/563 (0.36%)  2 2/561 (0.36%)  2
Hepatitis C  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Klebsiella sepsis  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Lung infection pseudomonal  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Pneumococcal sepsis  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Pneumonia  1  3/563 (0.53%)  3 3/561 (0.53%)  3
Pneumonia adenoviral  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Pneumonia staphylococcal  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Sepsis  1  32/563 (5.68%)  34 33/561 (5.88%)  35
Sepsis syndrome  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Septic shock  1  22/563 (3.91%)  22 31/561 (5.53%)  33
Staphylococcal bacteraemia  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Streptococcal bacteraemia  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Injury, poisoning and procedural complications     
Chemical poisoning  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Complications of bone marrow transplant  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Gun shot wound  1  2/563 (0.36%)  2 1/561 (0.18%)  1
Haemodialysis-induced symptom  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Haemothorax  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Medical device complication  1  5/563 (0.89%)  5 2/561 (0.36%)  2
Medication error  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Non-accidental overdose  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Operative haemorrhage  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Overdose  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Post procedural complication  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Post procedural haemorrhage  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Procedural complication  1  3/563 (0.53%)  3 0/561 (0.00%)  0
Road traffic accident  1  4/563 (0.71%)  4 1/561 (0.18%)  1
Splenic rupture  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Subdural haematoma  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Thermal burn  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Transplant failure  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Investigations     
Haematocrit decreased  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Oxygen saturation decreased  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Hypercalcaemia  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Hypocalcaemia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Hypophosphataemia  1  4/563 (0.71%)  4 1/561 (0.18%)  1
Lactic acidosis  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Metabolic acidosis  1  0/563 (0.00%)  0 5/561 (0.89%)  5
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukaemia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Acute myeloid leukaemia  1  2/563 (0.36%)  2 1/561 (0.18%)  1
Adenocarcinoma  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Bile duct cancer  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Carcinoma  1  0/563 (0.00%)  0 2/561 (0.36%)  2
Colon cancer  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Gastric cancer  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Hepatic neoplasm malignant  1  2/563 (0.36%)  2 1/561 (0.18%)  1
Leukaemia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Lip and/or oral cavity cancer  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Metastatic neoplasm  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Myelodysplastic syndrome  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Myeloid leukaemia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Neuroendocrine tumour  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Non-Hodgkin's lymphoma  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Ovarian cancer metastatic  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Renal cell carcinoma stage unspecified  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Nervous system disorders     
Anoxic encephalopathy  1  1/563 (0.18%)  1 2/561 (0.36%)  2
Cerebral haemorrhage  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Cerebral infarction  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Cerebral ischaemia  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Cerebrovascular accident  1  2/563 (0.36%)  2 1/561 (0.18%)  1
Coma  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Convulsion  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Haemorrhage intracranial  1  2/563 (0.36%)  2 3/561 (0.53%)  3
Hypoxic encephalopathy  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Ischaemic cerebral infarction  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  4/563 (0.71%)  4 2/561 (0.36%)  2
Acute respiratory failure  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Aspiration  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Bronchial obstruction  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Chronic obstructive airways disease  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Hypoxia  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Interstitial lung disease  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Pleural effusion  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Pneumothorax  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Pulmonary haemorrhage  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Pulmonary oedema  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Respiratory arrest  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Respiratory distress  1  2/563 (0.36%)  2 3/561 (0.53%)  3
Respiratory failure  1  2/563 (0.36%)  2 5/561 (0.89%)  5
Respiratory tract haemorrhage  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Tachypnoea  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Tracheal disorder  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Surgical and medical procedures     
Abscess drainage  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Aortic valve replacement  1  0/563 (0.00%)  0 2/561 (0.36%)  2
Cardiac operation  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Colectomy  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Coronary artery surgery  1  2/563 (0.36%)  2 0/561 (0.00%)  0
Thoracotomy  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Ventricular septal defect repair  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Vascular disorders     
Air embolism  1  1/563 (0.18%)  2 1/561 (0.18%)  1
Aortic aneurysm rupture  1  1/563 (0.18%)  1 2/561 (0.36%)  2
Aortic dissection  1  0/563 (0.00%)  0 3/561 (0.53%)  3
Aortic stenosis  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Haematoma  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Haemodynamic instability  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Haemorrhage  1  1/563 (0.18%)  1 1/561 (0.18%)  1
Hypoperfusion  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Hypotension  1  58/563 (10.30%)  82 50/561 (8.91%)  78
Hypovolaemic shock  1  0/563 (0.00%)  0 1/561 (0.18%)  1
Peripheral ischaemia  1  1/563 (0.18%)  1 0/561 (0.00%)  0
Shock  1  3/563 (0.53%)  3 0/561 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intensive Renal Replacement Therapy Less-intensive Renal Replacement Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/563 (0.00%)      0/561 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul M. Palevsky MD
Organization: VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh, PA
Phone: 410-360-3932
EMail: paul.palevsky@va.gov
Publications of Results:
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00076219    
Other Study ID Numbers: 530
First Submitted: January 15, 2004
First Posted: January 19, 2004
Results First Submitted: June 12, 2013
Results First Posted: August 16, 2013
Last Update Posted: August 23, 2013