NCT04703049

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

January 7, 2021

Last Update Submit

August 8, 2021

Conditions

Keywords

ViscosityContrastNephropathyCoronary Intervention

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • patients between ages 18 and 90
  • underwent PCI in our hospital between

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Hastanesi

Bursa, None Selected, 16320, Turkey (Türkiye)

Location

Related Publications (2)

  • Camci 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.

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

July 10, 2017

Primary Completion

October 31, 2017

Study Completion

November 30, 2017

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations