- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04703049
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
Conditions
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.
Sponsor
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.
General Publications
- Çamci S, Kinik M, Ari S, Ari H, Melek M, Bozat T. The predictive value of hemoglobin to creatinine ratio for contrast-induced nephropathy in percutaneous coronary interventions. Clin Chem Lab Med. 2022 Jun 22;60(9):1455-1462. doi: 10.1515/cclm-2022-0247. Print 2022 Aug 26.
- Kinik M, Camci S, Ari S, Ari H, Melek M, Bozat T. The effect of whole blood viscosity on contrast-induced nephropathy development in patients undergoing percutaneous coronary intervention. Postgrad Med. 2022 Jan;134(1):78-84. doi: 10.1080/00325481.2021.1997007. Epub 2021 Nov 10.
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.
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