Contrast Induced Nephropathy Among Vascular Patients Undergoing Lower Limb Angioplasty

NCT04879186 | Unknown

• 1 other identifier: 2020/2659
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast-induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• Contrast induced nephropathy

  Rise in creatinine post operatively according to KDIGO criteria

  1 week post procedure

Study Arms (1)

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

Interventions

Peripheral endovascular angioplasty PROCEDURE

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

Patients undergoing peripheral endovascular angioplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient data is drawn from the eHINTs Perioperative Subject Area, a previously curated datat mart which forms part of the SingHealth ODySSEy (On-prem Research Data Science and Systems Explorer) System. This is a registry of all patients who have undergone surgery in Singapore General Hospital. Patient identifier are removed before data release to the study team.

You may qualify if:

• All patients undergoing peripheral endovascular angioplasty during the study period, at Singapore General Hospital

You may not qualify if:

• Patients \< 21 years of age

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: July 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)