Informations générales (source: ClinicalTrials.gov)
Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH) (STRENGTH)
Interventional
N/A
European Cardiovascular Research Center (Voir sur ClinicalTrials)
mai 2016
mai 2018
29 juin 2024
The Strength study aim to evaluate the use of the RenalGuard device to protect the
patients at high risk to develop acute kidney injury following a complex cardiovascular
intervention requiring a high volume of contrast.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL PRIVE CLAUDE GALIEN | Philippe Garot | Contact (sur clinicalTrials) | |||
| HOPITAL PRIVE JACQUES CARTIER | Philippe Garot | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Clinique Pasteur - 31076 - Toulouse - France | Jean Fajadet | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Rangueil - 31059 - Toulouse - France | Didier Carrié | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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