Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00286403
Eligibility Criteria:
Inclusion Criteria:
* Post-operative patients with serum creatinine (Cr) rising 0.3 mg/dl or more than 25% above admission levels within a single 24-hour period will be considered eligible.
* Central Venous Access: \[CVP \> 6 cm H2O without mechanical ventilation\] \[CVP \> 9 cm H2O with mechanical ventilation\]
* Mean arterial pressure \> 70 mm Hg receiving up to two vasopressors including:
* Nor-epinephrine (0.01-1.5g/kg/min)
* Phenylephrine (0.1-7.0g/kg/min
* Vasopressin (0.1-1.5 mU/kg/min)
Exclusion Criteria:
* Patients with APACHE scores greater than 30 (or felt by the principal investigators to be unlikely survive more than 24 hours).
* Patients requiring 3 or more presser agents to maintain a MAP of 70 mm Hg or greater.
* Patients on two vasopressors with a MAP \< 70 mm Hg will not be considered for enrollment
* Patient with baseline serum Cr \> 3.0 mg/dl
* Patients with known bacteremia and/or the Systemic Inflammatory Response Syndrome (SIRS)
* Patients ATN secondary to aminoglycosides or amphotericin B or equivalent anti-fungal drug
* Patients on chronic peritoneal or hemodialysis
* Patients receiving acute peritoneal or hemodialysis during current hospitalization
* Patients on dopamine infusion within the previous 12 hours
* Patients with known HIV seropositivity and past history of opportunistic infection
* Pregnant or lactating women
* Patients with history of uncontrolled atrial or ventricular cardiac arrhythmia
* Patients under the influence of alcohol or other drugs
* Patients enrolled in a previous investigational study within15 days of enrollment
* Patients with a known hypersensitivity to fenoldopam mesylate
* Patients with a known history of glaucoma.
* Patients with cirrhosis of the liver and/or portal hypertension
* Patients with toxic levels of calcineurin inhibitors (FK-506 or CsA) or acute allograft rejection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00286403
Study Brief:
Protocol Section:
NCT00286403