Clinical trial NCT04592406: Data on the Prevention of Complications of Prophylactic Intravenous Hydration in Patients With eGFR < 30
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury (Nontraumatic)
Contrast-induced Nephropathy
Keywords: intravascular iodinated contrast administration
prophylactic intravenous hydration
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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+

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.

Eligibility criteria: 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

Primary outcomes:
measure: complications of prophylactic intravenous hydration
timeFrame: 14 days
measure: complications of prophylactic intravenous hydration 2
timeFrame: 14 days
measure: complications of prophylactic intravenous hydration 3
timeFrame: 14 days
Secondary outcomes:
measure: incidence of post-contrast acute kidney injury
timeFrame: 6 days
measure: incidences of 1-month post-contrast dialysis and mortality
timeFrame: 35 days
measure: post-contrast change in eGFR
timeFrame: 6 days
measure: prophylaxis administered
timeFrame: 1 day
measure: post-contrast AKI according to KDIGO definition
timeFrame: 6 days
measure: ODDS ratios prophylaxis
timeFrame: 1 month
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
Study officials:
References: