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

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ClinicalTrials.gov Identifier: NCT04703049
Recruitment Status : Completed
First Posted : January 11, 2021
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Hasan ARI, Bursa Postgraduate Hospital

Study Description
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Brief 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).

Condition or disease Intervention/treatment
Percutaneous Coronary Intervention Patients Other: Blood Viscosity Testing

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 Design
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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Elective Percutaneous Coronary Intervention
Actual Study Start Date : July 10, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04703049


Locations
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Turkey
Bursa Yüksek İhtisas Hastanesi
Bursa, None Selected, Turkey, 16320
Sponsors and Collaborators
Bursa Postgraduate Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hasan ARI, Professor Doctor, Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier: NCT04703049    
Other Study ID Numbers: YİEAH
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hasan ARI, Bursa Postgraduate Hospital:
Viscosity
Contrast
Nephropathy
Coronary Intervention
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases