The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Percutaneous Coronary Intervention

August 8, 2021 updated by: Hasan ARI, Bursa Postgraduate Hospital

The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Elective Percutaneous Coronary Intervention

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).

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • None Selected
      • Bursa, None Selected, Turkey, 16320
        • Bursa Yüksek İhtisas Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study started with the approval of the local ethics committee. Five hundred patients between ages 18 and 90 who underwent PCI in our hospital between July 10, 2017, and October 31, 2017, were prospectively included. Informed consent forms were obtained from the patients. Patients with chronic kidney disease (CKD) who underwent hemodialysis or peritoneal dialysis for this reason and patients who underwent to coronary bypass surgery within 48 h were excluded from the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast Induced Nephropathy
Time Frame: 48 to 72 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 8, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YİEAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Percutaneous Coronary Intervention Patients

Clinical Trials on Blood Viscosity Testing

Subscribe