Acute Kidney Injury, Pentoxifylline
Conditions
Brief summary
Acute kidney injury (AKI) has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. Therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from AKI. There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.
Detailed description
Acute kidney injury (AKI) refers to a clinical syndrome characterized by a rapid (hours to days) decrease in renal function, which is a common and important diagnostic and therapeutic challenge for clinicians. The disorder has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. AKI is independently associated with important morbidity and mortality although many efforts have been used in past years. Therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from AKI. There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We thus hypothesized that PTX may have therapeutic value for AKI in human. We thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.
Interventions
DRUGPentoxifylline 400Mg Tablet
Investigators with AKI will received oral pentoxifylline (400 mg) three times a day for 14 days or no pentoxifylline according to their decision.
Sponsors
Taipei Medical University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 20 \ 70 y/o who had admitted for acute kidney injury (renal function decreased within 48hours which meets following criteris: GFR decreased \> 25 %, serum creatinine elevated \> 0.3 mg/dl or 50%、urine amount less than 0.5 ml/kg/hour \> 6 hours).
Exclusion criteria
* 1\. Those who had been received regular dialysis or GFR \< 30 ml/min before test. 2. Those who with acute bleeding. 3. Those who allergy to pentoxifylline or methylxanthine derivatives (such as caffeine, theophylline and theobromine )..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal outcome | 4 weeks | Need of dialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function tests | 4 weeks | Serum and urine test (Blood urine nitrogen, Serum creatinine, Daily urine amount) |
| inflammation marker | 4 weeks | Transforming Growth Factor-β; Monocyte chemoattractant protein-1 |
Outcome results
None listed