Data on the Prevention of Complications of Prophylactic Intravenous Hydration in Patients With eGFR < 30
- Conditions
- Acute Kidney Injury (Nontraumatic)Contrast-induced Nephropathy
- Registration Number
- NCT04592406
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 443
- eGFR <30 mL/min/1.73m2 in absence of dialysis
- referred for a procedure with intravascular administration of iodinated contrast material at Maastricht UMC+
- age <18 years
- dialysis or pre-dialysis
- emergency or intensive care status
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complications of prophylactic intravenous hydration 2 14 days deaths with primary cause heart failure (and no known other underlying cause) within 14 days post-contrast
complications of prophylactic intravenous hydration 3 14 days proportion of all deaths in prophylaxis subgroups with primary cause heart failure within 14 days
complications of prophylactic intravenous hydration 14 days serious complications of prophylactic intravenous hydration (heart failure, arrhythmia)
- Secondary Outcome Measures
Name Time Method incidence of post-contrast acute kidney injury 6 days acute increase in serum creatinine within 5 days post-contrast
incidences of 1-month post-contrast dialysis and mortality 35 days incidences of dialysis and all-cause mortality within post-contrast
prophylaxis administered 1 day percentage of patients receiving standard, adapted and no prophylactic intravenous hydration
ODDS ratios prophylaxis 1 month 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
post-contrast AKI according to KDIGO definition 6 days post-contrast AKI according to KDIGO definition
post-contrast change in eGFR 6 days change in eGFR from baseline post-contrast
Trial Locations
- Locations (1)
Maastricht UMC
🇳🇱Maastricht, Netherlands