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NCT Number: NCT04592406

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CVP screening

Other

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.

Primary outcomes

  1. complications of prophylactic intravenous hydration

    Time frame: 14 days

    serious complications of prophylactic intravenous hydration (heart failure, arrhythmia)

  2. complications of prophylactic intravenous hydration 2

    Time frame: 14 days

    deaths with primary cause heart failure (and no known other underlying cause) within 14 days post-contrast

  3. complications of prophylactic intravenous hydration 3

    Time frame: 14 days

    proportion of all deaths in prophylaxis subgroups with primary cause heart failure within 14 days

Secondary outcomes

  1. incidence of post-contrast acute kidney injury

    Time frame: 6 days

    acute increase in serum creatinine within 5 days post-contrast

  2. incidences of 1-month post-contrast dialysis and mortality

    Time frame: 35 days

    incidences of dialysis and all-cause mortality within post-contrast

  3. post-contrast change in eGFR

    Time frame: 6 days

    change in eGFR from baseline post-contrast

  4. prophylaxis administered

    Time frame: 1 day

    percentage of patients receiving standard, adapted and no prophylactic intravenous hydration

  5. post-contrast AKI according to KDIGO definition

    Time frame: 6 days

    post-contrast AKI according to KDIGO definition

  6. ODDS ratios prophylaxis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study 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

Acronym: CVP

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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