Contrast Induced Nephropathy Among Vascular Patients Undergoing Lower Limb Angioplasty

Sponsor
Singapore General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04879186
Collaborator
(none)
1,500
1
72
20.8

Study Details

Study Description

Brief Summary

Contrast induced nephropathy (CIN) is an iatrogenic renal injury following intravascular administration of radio-opaque contrast media (CM) in susceptible individuals. As the third leading cause of hospital acquired renal failure, it is associated with increased mortality, morbidity and prolonged hospital stay. Endovascular procedures have gained greater popularity in the past decade due to the advance in technology. This has also led to the increased incidence of CIN after vascular surgeries. We are conducting a retrospective cohort study in Singapore General Hospital using our perioperative database collected in the past five years.

We will be extracting relevant patient perioperative information including both clinical diagnosis and lab values. Our primary aim is to establish the incidence of CIN among vascular patients with or without pre-existing chronic renal impairment undergoing elective peripheral endovascular angioplasty. Our secondary aims are to establish the risk factors and protective factors that lead to the development of CIN in vascular patients after peripheral endovascular angioplasty. We will also be looking at the long-term outcome of patients who have developed CIN after vascular endovascular angioplasty. The results of the study will enable us to identify patients at high risk of development of CIN, thus appropriate measures can be initiated early and help with their recovery process.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Peripheral endovascular angioplasty

Detailed Description

We propose a retrospective single-center cohort study conducted in Singapore general hospital. Data would be extracted in patients who have undergone peripheral endovascular angioplasty from 01/01/2015 to 01/01/2020. The data will be extracted from the eHINTs Perioperative Subject Area without any direct identifiers. The subject area has been previously curated as part of the SingHealth ODySSEy (On-prem Research Data Science and Systems Explorer) System. There will be no patient identifier collected and the data collection administration will not have any access to patient identifier. Waiver of consent is sought and no patient interaction would be required for the study.

The parameters to be extracted would include preoperative data such as patient demographics (age, gender, race, BMI), baseline comorbidities including but not limited to: hypertension, hyperlipidemia, diabetes mellitus, smoking, anemia, heart diseases (previous heart attack/history of congestive heart failure), preoperative renal function (measured by baseline Urea, creatinine, electrolytes level Na, K, Cl), preoperative long-term medication use including ACE inhibitor, ARB, beta-blocker, statin and diuretics and NSAIDS. Intraoperative data including types of anaesthesia used, operative duration, presence of intraoperative hypotension. Postoperative parameters such as mortality, length of stay in hospital and ICU, postoperative renal function measured by urea and creatinine level within 3 days and one month postoperatively.

Statistical analysis will be performed to study the risk factors for CIN in patients undergoing peripheral endovascular angioplasty.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Cohort Study Investigating the Risk Factors and Long-term Outcome of Contrast Induced Nephropathy Among Vascular Patients Undergoing Lower Limb Angioplasty
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing peripheral endovascular angioplasty

Patients undergoing peripheral endovascular angioplasty. No intervention other than what was already completed as part of routine clinical care, as this is a retrospective cohort.

Procedure: Peripheral endovascular angioplasty
Peripheral endovascular angioplasty - using endovascular techniques to treat peripheral artery occlusive lesions.

Outcome Measures

Primary Outcome Measures

  1. Contrast induced nephropathy [1 week post procedure]

    Rise in creatinine post operatively according to KDIGO criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients undergoing peripheral endovascular angioplasty during the study period, at Singapore General Hospital
Exclusion Criteria:
  • Patients < 21 years of age

Contacts and Locations

Locations

Site City State Country Postal Code
1 Singapore General Hospital Singapore Singapore 169608

Sponsors and Collaborators

  • Singapore General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT04879186
Other Study ID Numbers:
  • 2020/2659
First Posted:
May 10, 2021
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2021