PatientsVille.com LogoPatientsVille.com

Acute Kidney Injury | A Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery

Acute Kidney Injury research study

What is the primary objective of this study?

The objectives of the study are the following: - To evaluate the pharmacokinetic profile of Sildenafil in cardiac surgery patients at risk of acute kidney injury - To determine the safety and tolerability of Sildenafil in cardiac surgery patients at risk of acute kidney injury

Who is eligible to participate?

Inclusion Criteria: 1. Adult cardiac surgery patients (>18 years) undergoing cardiac surgery with moderately hypothermic CPB (32-34°C) and blood cardioplegia 2. Identified as representing a high risk group for acute kidney injury using a modified risk score based on the variables of Age, Sex, BMI, Smoking Status, NHYA class, Previous Operations, Peripheral Vascular Disease, Diabetes, Hypertension, Pre-operative Haemoglobin level, Pre-operative eGFR, Operative Priority, Operation Type, Ejection Fraction and Presence of Pre-Operative Critical Events. 3. Female subjects of childbearing potential are not to be pregnant (to be confirmed by urine human chorionic gonadotropin pregnancy test prior to dosing). Women are considered not to be of childbearing potential if they have been surgically sterilised (eg, tubal ligation, oophorectomy or hysterectomy) or are postmenopausal (defined as serum follicle-stimulating hormone level of ≥30 IU/mL) in the absence of hormone replacement therapy and complete absence of menses for at least 24 consecutive months. Exclusion Criteria: 1. Emergency or salvage procedure 2. Ejection fraction <30% 3. CKD Stage 5, defined as eGFR<15ml/min or renal replacement therapy. 4. Administration of potent CYP 3A4 inhibitors within 1 month prior to study participation (e.g. HIV protease inhibitors, imidazole antifungals and erythromycin, please see Appendix 1 for a full list of prohibited medications). 5. Administration of nitrate medicines (e.g. glyceryl trinitrate within 24 hours of surgery. 6. Any ongoing malignancy, or prior malignancy that currently requires treatment. 7. Patients allergic to any other PDE-5 Inhibitor 8. Patients who are participating in another interventional clinical study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Kidney Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SildenafilThe active study drug, Revatio®, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate. The active study medication is supplied in single use glass vials and as a clear, colourless, sterile, ready-to-use solution containing 10 mg (12.5 mL) of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate, 50.5 mg dextrose and water for injection. Sildenafil is manufactured under Good Manufacturing Practice (EU-GMP) by Pfizer Inc

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

SildenafilAll subjects in groups 1-6 will receive SIldenafil but in escalating doses.

Study Status

Completed

Start Date: June 2013

Completed Date: December 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Area under the plasma concentration versus time curve and Plasma Concentration of Sildenafil

Secondary Outcome: Serum creatinine and Biochemical markers of AKI

Study sponsors, principal investigator, and references

Principal Investigator: Gavin Murphy, Prof

Lead Sponsor: University of Leicester

Collaborator: British Heart Foundation

More information:https://clinicaltrials.gov/show/NCT02136329

Discuss Viagra