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NCT Number: NCT03205410

Remote Ischemic Preconditioning as a New Method of Nephroprotection

Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way using serum creatinine concentration (SCr) and with use of serum level of neutrophil gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury. Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Cardiac Therapy Clinic

Lodz, 92-213, Poland

About this study

Cardiac surgery patients have a high risk of AKI. The development of AKI is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. However, there are no effective clinical strategies for preventing prevalence of AKI. RIPC as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. That makes RIPC under the area of interests of many researches which apply this method to prevent AKI. Investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative AKI, in which want to check wether RIPC reduce the prevalence of AKI, according Kidney Disease: Improving Global Outcomes (KDIGO) definition, by increase in SCr. Furthermore researchers want to investigate a benefit from RIPC in reduction of level of SCr and higher glomerular filtration rate (GFR) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of NGAL an early biomarker of AKI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischemic preconditioning

Procedure

The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.

Other names: RIPC

no - remote ischemic preconditioning

Procedure

The sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.

Other names: no-RIPC

Primary outcomes

  1. incidence of acute kidney injury within 72 hours after cardiac surgery

    Time frame: 72 hours after cardiac surgery

    increase in serum creatinine level by more than 50% or more than 0.3mg/dL from baseline within 72 h after surgery

  2. NGAL level

    Time frame: 3 hours after cardiac surgery

    increased NGAL level within 3 hours after cardiac surgery

Secondary outcomes

  1. length of hospitalization

    Time frame: through hospitalization completion, an average of 14 days

    time until discharge from the hospital

  2. length of intensive care unit (ICU) stay

    Time frame: through ICU stay completion, an average of 5 days

    time until discharge from ICU

  3. ventilation time

    Time frame: through ICU stay completion, an average of 5 days

    time of mechanical ventilation

  4. occurrence of postoperative atrial fibrillation

    Time frame: through ICU stay completion, an average of 5 days

    incidence of atrial fibrylation in continous electrocardiogram registration

  5. time of renal replacement therapy

    Time frame: through ICU stay completion, an average of 5 days

    days of renal replacement therapy

  6. death

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

    death from any cause

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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