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

Remote Ischemic Preconditioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761368
• Other study ID #: RNN/219/13/KE
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2018
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast Induced - Acute Kidney Injury
• Ischemia
• Remote Ischemic Preconditioning
• Wounds and Injuries

Intervention

Procedure:
• Remote Ischemic Preconditioning
four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff
• Sham Remote Ischemic Preconditioning
deflated cuff placed on the left arm for 40 min

Locations

Country	Name	City	State
Poland	Intensive Cardiac Therapy Clinic	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Contrast Induced-Acute Kidney Injury	absolute rise of = 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline	48 to 72 hours after contrast exposure
Secondary	Number of Participants With Need of Renal Replacement Therapy	qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)	up to 7 days after contrast exposure
Secondary	Number of Participants Who Presented Cardiogenic Shock	sustained hypotension (systolic blood pressure < 90 mm Hg for =30 min)	up to 7 days after contrast exposure
Secondary	Death of Any Cause	Number of patients who died.	up to one month after contrast exposure