NCT03761368

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

Completed NA Results posted Last updated 19 November 2020

What this trial tests

NA trial testing Remote Ischemic Preconditioning in Remote Ischemic Preconditioning in 101 participants. Completed in 30 June 2018.

Timeline

1 March 2015

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	Medical University of Lodz
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	101
Start date	1 March 2015
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	1 location across Poland

Drugs / interventions tested

• Remote Ischemic Preconditioning
• Sham Remote Ischemic Preconditioning

Conditions studied

• Remote Ischemic Preconditioning — all drugs for Remote Ischemic Preconditioning →
• Contrast Induced - Acute Kidney Injury — all drugs for Contrast Induced - Acute Kidney Injury →

Sponsor

Medical University of Lodz

Who can join

18 and older, any sex, with Remote Ischemic Preconditioning or Contrast Induced - Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Contrast Induced-Acute Kidney Injury Primary · 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

Group	Value	95% CI
RIPC Group	2
Control Group	3

Number of Participants With Need of Renal Replacement Therapy Secondary · 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)

Group	Value	95% CI
RIPC Group	0
Control Group	0

Number of Participants Who Presented Cardiogenic Shock Secondary · up to 7 days after contrast exposure

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

Group	Value	95% CI
RIPC Group	1
Control Group	1

Death of Any Cause Secondary · up to one month after contrast exposure

Number of patients who died.

Group	Value	95% CI
RIPC Group	0
Control Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: up to one month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RIPC Group

Serious: 1/50 (2%)

Deaths: 0/50

Control Group

Serious: 1/51 (2%)

Deaths: 0/51

Serious adverse events (1 terms)

Reaction	System	RIPC Group	Control Group
Cardiogenic shock	Cardiac disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	RIPC Group	Control Group
skin petechiae	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Cardiogenic shock.

Data from ClinicalTrials.gov NCT03761368 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Remote Ischemic Preconditioning and Contrast-Induced Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention: A Randomized Clinical Trial.
   Stokfisz K, Ledakowicz-Polak A, Kidawa M, Zielinska M. · · 2020 · cited 4× · PMID 32874376 · DOI 10.1016/j.curtheres.2020.100599