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Completed

NCT Number: NCT03761368

Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI

Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC reduces the incidence of CI-AKI measured standard way of using SCr concentration but also with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective coronary angiography (CA) followed by percutaneous coronary intervention (PCI).

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Key information

Conditions

Remote Ischemic Preconditioning Contrast Induced - Acute Kidney Injury

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

Nowadays CI-AKI is defined according to serum creatinine concentration (SCr) as any of the following: (1) an absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or (2) a relative increase of 25% in serum creatinine compared to baseline within 48 to 72 hours after contrast administration. In the last decades, several novel biomarkers of AKI have been studied including neutrophil gelatinase-associated lipocalin (NGAL). Furthermore, remote ischemic preconditioning (RIPC) turned out to be one of the most promising and intriguing non-pharmacological strategy. This simple procedure consisting of brief, non-lethal episodes of ischemia and reperfusion applied in one tissue or organ protects remote tissues or organs from subsequent injury.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged over 18 years
  • patients with stable angina pectoris
  • patients admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz with intention of elective CA with follow-up PCI.

Exclusion criteria

  • history of severe injuries up to 2 months before intervention
  • history of surgeries up to 2 months before intervention
  • history of cancer,
  • acute inflammation during hospitalization
  • chronic autoimmunologic diseases
  • patients needing hemodialysis
  • chronic kidney disease in stage 4 or 5 (eGFR<30 ml/min/1,73m2)
  • peripheral vascular disease affecting upper limbs.

Treatment and study plan

Remote ischemic preconditioning

Procedure

four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff

Other names: RIPC

Sham remote ischemic preconditioning

Procedure

deflated cuff placed on the left arm for 40 min

Other names: Sham RIPC

Primary outcomes

  1. Number of Participants With Contrast Induced-Acute Kidney Injury

    Time frame: 48 to 72 hours after contrast exposure

    absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline

Secondary outcomes

  1. Number of Participants With Need of Renal Replacement Therapy

    Time frame: up to 7 days after contrast exposure

    qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)

  2. Number of Participants Who Presented Cardiogenic Shock

    Time frame: up to 7 days after contrast exposure

    sustained hypotension (systolic blood pressure < 90 mm Hg for ≥30 min)

  3. Death of Any Cause

    Time frame: up to one month after contrast exposure

    Number of patients who died.

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2018
Registry last updated
Nov 19, 2020

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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