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

Data on the Prevention of Complications of Prophylactic Intravenous Hydration in Patients With Estimated Glomerular Filtration Rate (eGFR) < 30 ml/Min/1.73m2 From the Maastricht UMC+ Contrast Voorbereidings Polikliniek

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.

Study Overview

• Status: Completed
• Conditions: Contrast-induced Nephropathy; Acute Kidney Injury (Nontraumatic)
• Intervention / Treatment: Other: CVP screening

Detailed Description

A large retrospective observational study, including 4-years of elective procedures with intravascular iodinated contrast administration in eGFR<30mL/min/1.73m2 patients at Maastricht UMC+, found that prophylactic intravenous hydration might confer some benefit for renal function. For patients who had received prophylactic hydration, adjusted odds ratios for risk of post-contrast acute kidney injury, and 1-month eGFR decline and dialysis were all lower than 1. These results were not significant, but suggest that hydration may be protective. On the other hand, adjusted odds ratios for all-cause mortality within 1-month post-contrast were higher than 1, with point estimates indicating a trend toward higher risk of short-term mortality after prophylaxis as compared to no prophylaxis. Confounding by indication may be responsible for the observed increased risk of short-term mortality, but complications of the prophylaxis did contribute towards the risk. Amongst the 281 eGFR<30mL/min/1.73m2 prophylaxis patients studied, 18 (6.4%) serious complications occurred: 3 arrhythmias, and 15 heart failures including 5 deaths. Of all 21 deaths recorded for the prophylaxis patients, 24% (5/21) were considered to be related to intravenous fluids. An exploration of differences in baseline characteristics between patients with and without serious complications suggested that these can be avoided if cardiac function parameters are given extra and individual attention before deciding whether to administer prophylaxis to high-risk patients with eGFR<30mL/min/1.73m2. At Maastricht UMC+ a specialised unit (called the CVP) 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. In order to enable real function follow-up, the CVP registers data on all patients with eGFR <30 receiving intravascular iodinated contrast material, including acute patients who did not receive the dual screening process prior to prophylactic intravenous hydration. The current study aims to describe post-contrast outcomes of patients to whom the CVP screening method has been applied and to compare them to earlier outcomes of patients to whom the screening was not applied.

• Study Type: Observational
• Enrollment (Actual): 443

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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+

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of post-contrast acute kidney injury	acute increase in serum creatinine within 5 days post-contrast	6 days
incidences of 1-month post-contrast dialysis and mortality	incidences of dialysis and all-cause mortality within post-contrast	35 days
post-contrast change in eGFR	change in eGFR from baseline post-contrast	6 days
prophylaxis administered	percentage of patients receiving standard, adapted and no prophylactic intravenous hydration	1 day
post-contrast AKI according to KDIGO definition	post-contrast AKI according to KDIGO definition	6 days
ODDS ratios prophylaxis	where possible odds ratios for standard prophylaxis versus no prophylaxis and adapted prophylaxis versus no prophylaxis will be calculated for post-contrast acute kidney injury, 1-month dialysis and death	1 month

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: intravascular iodinated contrast administration; prophylactic intravenous hydration
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: NL.MUMC.AMACINGrp.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No