Data on the Prevention of Complications of Prophylactic Intravenous Hydration in Patients With eGFR < 30

NCT04592406 | Completed

• 1 other identifier: NL.MUMC.AMACINGrp.4
• Study Type: observational
• Target: 443
• Locations: 1 country
• Sites: 1

Brief Summary

At Maastricht University Medical Centre (Maastricht UMC+) a specialised unit was established where a dual screening process including both renal and cardiac parameters is used to minimize the risk of contrast-induced acute kidney injury as well as the risk of prophylactic hydration in eGFR\<30mL/min/1.73m2 patients. Very little data exists on patients with eGFR \<30mL/min/1.73m2 in this context. The current study aims to describe post-contrast outcomes of patients to whom this screening method has been applied.

Conditions

Acute Kidney Injury (Nontraumatic); Contrast-induced Nephropathy

Keywords

intravascular iodinated contrast administration; prophylactic intravenous hydration

Outcome Measures

Primary Outcomes (3)

• complications of prophylactic intravenous hydration

  serious complications of prophylactic intravenous hydration (heart failure, arrhythmia)

  14 days

• complications of prophylactic intravenous hydration 2

  deaths with primary cause heart failure (and no known other underlying cause) within 14 days post-contrast

  14 days

• complications of prophylactic intravenous hydration 3

  proportion of all deaths in prophylaxis subgroups with primary cause heart failure within 14 days

  14 days

Secondary Outcomes (6)

• incidence of post-contrast acute kidney injury

  6 days

• incidences of 1-month post-contrast dialysis and mortality

  35 days

• post-contrast change in eGFR

  6 days

• prophylaxis administered

  1 day

• post-contrast AKI according to KDIGO definition

  6 days

Interventions

CVP screening OTHER

An appropriate dual screening process including both renal and cardiac parameters to minimize the risks of post-contrast renal adverse outcomes and of prophylactic hydration in eGFR\<30mL/min/1.73m2 patients.

Eligibility Criteria

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

Study Population

patients with eGFR \<30 mL/min/1.73m2 in absence of dialysis referred for a procedure with intravascular administration of iodinated contrast material at Maastricht UMC+

You may qualify if:

• eGFR \<30 mL/min/1.73m2 in absence of dialysis
• referred for a procedure with intravascular administration of iodinated contrast material at Maastricht UMC+

You may not qualify if:

• age \<18 years
• dialysis or pre-dialysis
• emergency or intensive care status

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 19, 2020
• Study Start: December 1, 2018
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)