Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI

Launched by EUROPEAN CARDIOVASCULAR RESEARCH CENTER · Jun 3, 2016

Keywords

ClinConnect Summary

The Strength Trial is a randomized, international (France and Germany) and multicentre (7) trial.

The patients population targeted is suffering from kidney insufficiency (estimated Glomerular Filtration Rate (eGFR) between 15 to 40 ml/min/m2) need to go through a complex cardiovascular intervention..

This is a population of patients at high risk to develop AKI following contrast media administration and complex cardiovascular interventions require a high amount of contrast.

Standard treatment is hydration but with risk of hyper and hypohydration for this population of patients. RenalGuar...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 years old
• • 15 ml/min/m2 ≤ eGFR ≤ 40 ml/min/m2
• • High volume contrast-requiring cardiovascular procedures (estimated contrast volume \> 3 times eGFR value)
• • Patient has agreed to all FU testing
• Exclusion Criteria:
• • Administration of iodine contrast media within 5 days before index procedure
• • Emergency procedure or primary PCI
• • Patients with pulmonary edema or cardiogenic shock (Killip 3 or 4)
• • Hypoxemia defined as SaO2 ≤ 90% and/or PaO2 ≤ 80 mmHg on room air
• • Acute Kidney Injury requiring dialysis before the procedure
• • Multiple myeloma or cancer treated with chemotherapy
• • Subjet is anuric
• • Subject has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month
• • Known hypersensitivity to furosemide active ingredient or excipient
• • Renal insufficiency with oligoanuria resistant to furosemide or caused by nephrotoxic or hepatotoxic substances
• • Pre-coma or coma induced by an hepatic encephalopathy
• • Severe hypokalemia, sever hyponatremia, hypovolemia with or without hypotension or dehydration
• • Hypersensitivity to sulfamides
• • Enrollment in another study unless the study is a registry or unless primary endpoint is reached
• • Expected life expectancy \< 1 year
• • Pregnant or breastfeeding patient
• • Patient under trusteeship or guardianship
• • Patient is unable / unwilling to provide an informed consent