Remote Ischemic Preconditioning as a New Method of Nephroprotection

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03205410
• Date of registration: 29/06/2017
• Prospective Registration: No
• Primary sponsor: Medical Universtity of Lodz
• Public title: Remote Ischemic Preconditioning as a New Method of Nephroprotection
• Scientific title: Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery
• Date of first enrolment: January 1, 2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03205410
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Marzenna Zielinska, MD,PhD,Prof.
• Affiliation: Medical University of Lodz

Key inclusion & exclusion criteria

Inclusion Criteria:

- Human patients with coronary artery disease.

Exclusion Criteria:

- history of cardiac surgery,

- acute myocardial infarction up to 7 days before surgery,

- chronic kidney disease in 4th or 5th stadium (eGFR<30 ml/min/1,73m2),

- peripheral vascular disease affecting upper limbs,

- history of severe injuries and surgeries in 2 months before cardiac surgery,

- history of cancer, acute inflammation during hospitalization,

- chronic autoimmunology diseases,

- dialysis patients.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Kidney Injury

Intervention(s)

Procedure: no - remote ischemic preconditioning

Procedure: remote ischemic preconditioning

Primary Outcome(s)

incidence of acute kidney injury within 72 hours after cardiac surgery [Time Frame: 72 hours after cardiac surgery]

NGAL level [Time Frame: 3 hours after cardiac surgery]

Secondary Outcome(s)

length of intensive care unit (ICU) stay [Time Frame: through ICU stay completion, an average of 5 days]

length of hospitalization [Time Frame: through hospitalization completion, an average of 14 days]

time of renal replacement therapy [Time Frame: through ICU stay completion, an average of 5 days]

ventilation time [Time Frame: through ICU stay completion, an average of 5 days]

occurrence of postoperative atrial fibrillation [Time Frame: through ICU stay completion, an average of 5 days]

death [Time Frame: from date of randomization until the date of death from any cause, assessed up to 2 years]

Secondary ID(s)

RNN/286/13/KE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors