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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04703049
Other study ID # YIEAH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 10, 2017
Est. completion date November 30, 2017

Study information

Verified date August 2021
Source Bursa Postgraduate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In our study, we aimed to investigate how whole blood viscosity (WBV) affects the development of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary intervention (PCI).


Description:

In our study, 500 patients who applied to the cardiology clinic and underwent PCI for elective procedure, ST segment elevation myocardial infarction (STEMI), and non-STEMI were prospectively included. Before the procedure, we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date November 30, 2017
Est. primary completion date October 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - patients between ages 18 and 90 - underwent PCI in our hospital between Exclusion Criteria: - Patients with chronic kidney disease (CKD) who underwent hemodialysis or peritoneal dialysis - Patients who underwent to coronary bypass surgery within 48 h were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood Viscosity Testing
we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (=0.5 mg/dl) or relative increase (=25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.

Locations

Country Name City State
Turkey Bursa Yüksek Ihtisas Hastanesi Bursa None Selected

Sponsors (1)

Lead Sponsor Collaborator
Bursa Postgraduate Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Contrast Induced Nephropathy CIN was defined as an increase in serum creatinine levels greater than 0.5 mg/dl or 25% or more increase compared to basal serum creatinine levels 48 to 72 h after exposure. 48 to 72 hours