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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Kidney Injury (Nontraumatic), Contrast-induced Nephropathy

Intervention / Treatment
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* Other: CVP screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravascular iodinated contrast administration, prophylactic intravenous hydration