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

Contrast-induced Nephropathy Clinical Trial

— CVP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592406
• Other study ID #: NL.MUMC.AMACINGrp.4
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: January 6, 2023

Study information

• Verified date: January 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: January 6, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury (Nontraumatic)
• Contrast-induced Nephropathy

Intervention

Other:
• CVP screening
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.

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications of prophylactic intravenous hydration	serious complications of prophylactic intravenous hydration (heart failure, arrhythmia)	14 days
Primary	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
Primary	complications of prophylactic intravenous hydration 3	proportion of all deaths in prophylaxis subgroups with primary cause heart failure within 14 days	14 days
Secondary	incidence of post-contrast acute kidney injury	acute increase in serum creatinine within 5 days post-contrast	6 days
Secondary	incidences of 1-month post-contrast dialysis and mortality	incidences of dialysis and all-cause mortality within post-contrast	35 days
Secondary	post-contrast change in eGFR	change in eGFR from baseline post-contrast	6 days
Secondary	prophylaxis administered	percentage of patients receiving standard, adapted and no prophylactic intravenous hydration	1 day
Secondary	post-contrast AKI according to KDIGO definition	post-contrast AKI according to KDIGO definition	6 days
Secondary	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