Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05283512
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2022-02-25
Brief Title:
Intravenous vs Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Intravenous vs Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease ENRICH A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENRICH
Brief Summary:
The use of contrast media CM poses a risk of post-contrast acute kidney injury PC-AKI especially among patients chronic kidney disease CKD International guidelines recommend intravenous IV hydration with isotonic 09 NaCl for three-four hours pre-contrast and four-six hours post-contrast Recent studies have proven that oral hydration or no hydration is non-inferior to IV hydration in patients with mild to moderate CKD eGFR 30-60 mLmin173 m2 However no randomized controlled trials have evaluated alternative hydration methods against the guideline-recommended hydration protocol for the prevention of PC-AKI in high-risk patients with severe CKD eGFR 30 mLmin173 m2
Thus the main focus of this trial is to evaluate IV hydration vs oral hydration for their efficacy to prevent of PC-AKI in patients with severe CKD who are scheduled for an elective contrast-enhanced CT-scan CECT with IV contrast-administration
Our research hypotheses consist of the following
1 Oral hydration with bottled tap water is non-inferior to IV-hydration with isotonic 09 NaCl as renal prophylaxis to prevent PC-AKI in patients with severe CKD referred for an elective IV CECT
2 NGAL and cfDNA are early and precise plasma and urinary biomarkers of PC-AKI with excellent diagnostic and prognostic accuracy for PC-AKI dialysis renal adverse events hospitalization progression in CKD-symptoms and all-cause mortality
Thus the main focus of this trial is to evaluate IV hydration vs oral hydration for their efficacy to prevent of PC-AKI in patients with severe CKD who are scheduled for an elective contrast-enhanced CT-scan CECT with IV contrast-administration
Our research hypotheses consist of the following
1 Oral hydration with bottled tap water is non-inferior to IV-hydration with isotonic 09 NaCl as renal prophylaxis to prevent PC-AKI in patients with severe CKD referred for an elective IV CECT
2 NGAL and cfDNA are early and precise plasma and urinary biomarkers of PC-AKI with excellent diagnostic and prognostic accuracy for PC-AKI dialysis renal adverse events hospitalization progression in CKD-symptoms and all-cause mortality
Detailed Description:
Trial design
This study is a pragmatic investigator-iniated single-centre open-labelled parallel-group non-inferiority randomized controlled trial with two parallel arms Patients will randomly be allocated to preventive treatment with IV hydration or oral hydration
Participants and study setting
The ENRICH-trial is conducted at Odense University Hospital OUH which is a tertiary health-care centre The referral area covers the region of Southern Denmark which corresponds to 125 million citizens in 22 municipalities of both urban and rural environment The trial enrols high-risk patients with an eGFR 30 mLmin173 m2 scheduled for IV CECT using approximately 50-150 mL of CM GE Healthcare Omnipaque 500 mL osmolality 350 mg ImL
The study population will consist of patients who are referred for an elective IV CECT in the work-up for treatment of CVD eg transaortic valve-implantation ablation endocarditis etc or suspected CVD eg angina etc suspected cancer thoracicabdominalurogenital diseases or cardiovascular work-up before kidney transplantation Patients referred for an acute or subacute IV CECT with competing etiologies for PC-AKI eg sepsis acute tubular necrosis cardiogenic shock etc will not be considered eligible for inclusion
Randomization
The randomized allocation to preventive treatment with either IV-hydration or oral hydration will be performed in REDCap which is computer-based tool provided by our collaborator Open Patient data Explorative Network OPEN The randomization sequence list is generated and implemented in the computer-based randomization tool by our data manager and will remain unknown throughout the study period
The randomization will be performed as 2-4-2 block randomization with stratification for DM-status CKD-stage eGFR 15 mLmin173 m2 or 15-29 mLmin173 m2 and the basis of referral for IV CECT kidney transplantation or other diseases Participants are then followed for a 30-day period with standard blood testing for kidney function at two-five days after IV CECT and a 30-day follow-up for the key secondary outcomes
Definition of PC-AKI
PC-AKI is defined in accordance with the KDIGO-guidelines which is a relative increase in serum creatinine SCr 50 from baseline or an absolute increase of SCr 03 mgdL from baseline
Course of action
High-risk patients with severe CKD eGFR 30 mLmin173 m2 and a scheduled IV CECT will be considered for eligibility Eligible patients will be screened according to the studys inclusionexclusion criteria Eligibility is assessed from the patients electronic health record EHR which contains data regarding health status and recent test results for evaluation of renal function
Eligible patients will be presented to the guideline-recommendations for preventive treatment with IV hydration along with blood sampling for evaluation of their renal function seven days prior to the IV CECT at the time of the scheduling of their IV CECT according to normal routine at Odense University Hospital Furthermore the patients will be presented with a short introduction to this study If the patient is interested heshe will be contacted by the lead investigators after which a verbal consent to participate in the study is obtained approximately seven to 14 days prior to the scheduled IV CECT
After the verbal consent is given the guideline-required evaluation of renal function seven days prior to their IV CECT will be planned along with an additional blood sample to evaluate the renal function one-three days prior to their IV CECT Furthermore blood samples to evaluate renal function will be planned at two-three days four-five days and 30 days after IV CECT along with follow-up consultations four-five days and 30 days after IV CECT
A thorough presentation of the study-information will be given by one of the lead investigators at baseline while the patient has been informed about the possibility of bringing an assessor of their choice The information will be delivered in a quiet room which is solely used to deliver patient information The lead investigators will make sure that the presentation is given within a reasonable timeframe prior to their scheduled IV CECT
During the presentation of the study the patient will be informed of the purpose of the study and the written patient information will be sent via e-mail or physically handed to the patient if desired Patients will be given as much time as wanted to decide if they wish to participate in the study after the oral information has been given Patients will be offered the possibility to call or physically meet with one of the lead investigators in case of additional questions before signing the informed consent
Subjects can leave the study at any time for any reason if they wish to do so without any clinical consequences Signed informed consent will be provided prior to any research procedures A subject is considered enrolled in the study once the subject is randomized
Patient data from EHR will be obtained according to the REDCap-database and the study endpoints after the verbal consent is delivered
Participant retention follow-up and withdrawal
Once a patient is enrolled and randomized the research group will make every reasonable effort to follow the patient for the entire study period If the patient fails to attend their appointment for blood sampling to evaluate renal function the patient will be contacted by telephone and a new appointment for blood sampling is scheduled within the next 24 hours The patient will only be excluded from the study after randomization if the patient does not receive the preventive treatment according to the randomization or if the IV CECT is cancelled after randomization and preventive treatment The rate of loss-to-follow-up for the primary and secondary outcomes are expected to be 10
Variables
Standard blood parameters to evaluate renal function will be obtained 90 days seven days one-three days and at baseline prior to the scheduled IV CECT Furthermore an urine sample for albuminecreatinine ratio mgg will be obtained at baseline before CM exposure The standard blood parameters will also be obtained two-three days andor four-five days and 25-40 days after the scheduled IV CECT Additional blood sampling to evaluate renal function will be performed at seven days andor 14-21 days after IV CECT if the patient has increasing SCr four-five days after IV CECT consistent with PC-AKI
The standard blood parameters for patients referred for IV CECT consist of the following Hemoglobin mM erythrocytes countL SCr μmolL eGFR mLmin173 m2 albumine μmolL sodium mM and potassium mM
The prospective cohort is followed over a 30-day period for events of dialysis treatment renal adverse events hospitalization due to hydration- or contrast-related sequelae ie symptomatic heart failure arrythmias renal insufficiency hyponatremia or hypernatremia and all-cause mortality
Progression in CKD-symptoms will be obtained from registration of uremic symptoms through a medical interview at baseline and 30 days after IV CECT A trained interviewer will identify any clinical signs of progression in CKD within the 30-day follow-up Progression in CKD is defined as progression in uremic symptoms which consist of the following
- Weight loss loss of appetite cramps nausea vomiting pruritus bruising fatigue peripheral edema impaired consciousness and changes in sense of taste
The medical history medicine use and echocardiography will be obtained at baseline before initiation of the hydration protocol The patient will then tend to their IV CECT
Blood- and urine samples for biomarkers of PC-AKI will be collected before IV CECT and three-four hours after IV CECT
The admission time is defined as the timespan between the start and the completion of the preventive treatment which is registered as date-month-year-hours-minutes
Dates and reasons for hospital admission 90 days before IV CECT will also be registered along with additional contrast exposure within the 30-day follow-up period after the scheduled IV CECT
The following parameters will also be obtained for the subgroup of participants who are referred for a cardiac IV CECT
Estimated coronary artery calcification score CAC-score
Stenosis 50 of the left main coronary artery LM
The grade of stenosis will be analyzed if present in the coronary arteries LM left anterior descending artery LAD left circumflex artery LCx and right coronary artery RCA
Aortic valve calcification AVC and mitral annulus calcification MAC
Calcification Agatson-score of the aorta aorta ascendens arcus aorta and aorta descendens the suprarenal and infrarenal aorta and the renal arteries
The diameter of aorta aorta ascendens arcus aorta aorta descendens and iliac arteries
The size of the left atrium cm2
Safety
An interim analysis will be performed after inclusion of 127 patients to evaluate the primary outcomes and the key secondary outcomes The steering committee will consider terminating the study preliminary if the analyses conclude a significant difference in the incidence of the primary andor the key secondary outcomes between the two groups
This study is a pragmatic investigator-iniated single-centre open-labelled parallel-group non-inferiority randomized controlled trial with two parallel arms Patients will randomly be allocated to preventive treatment with IV hydration or oral hydration
Participants and study setting
The ENRICH-trial is conducted at Odense University Hospital OUH which is a tertiary health-care centre The referral area covers the region of Southern Denmark which corresponds to 125 million citizens in 22 municipalities of both urban and rural environment The trial enrols high-risk patients with an eGFR 30 mLmin173 m2 scheduled for IV CECT using approximately 50-150 mL of CM GE Healthcare Omnipaque 500 mL osmolality 350 mg ImL
The study population will consist of patients who are referred for an elective IV CECT in the work-up for treatment of CVD eg transaortic valve-implantation ablation endocarditis etc or suspected CVD eg angina etc suspected cancer thoracicabdominalurogenital diseases or cardiovascular work-up before kidney transplantation Patients referred for an acute or subacute IV CECT with competing etiologies for PC-AKI eg sepsis acute tubular necrosis cardiogenic shock etc will not be considered eligible for inclusion
Randomization
The randomized allocation to preventive treatment with either IV-hydration or oral hydration will be performed in REDCap which is computer-based tool provided by our collaborator Open Patient data Explorative Network OPEN The randomization sequence list is generated and implemented in the computer-based randomization tool by our data manager and will remain unknown throughout the study period
The randomization will be performed as 2-4-2 block randomization with stratification for DM-status CKD-stage eGFR 15 mLmin173 m2 or 15-29 mLmin173 m2 and the basis of referral for IV CECT kidney transplantation or other diseases Participants are then followed for a 30-day period with standard blood testing for kidney function at two-five days after IV CECT and a 30-day follow-up for the key secondary outcomes
Definition of PC-AKI
PC-AKI is defined in accordance with the KDIGO-guidelines which is a relative increase in serum creatinine SCr 50 from baseline or an absolute increase of SCr 03 mgdL from baseline
Course of action
High-risk patients with severe CKD eGFR 30 mLmin173 m2 and a scheduled IV CECT will be considered for eligibility Eligible patients will be screened according to the studys inclusionexclusion criteria Eligibility is assessed from the patients electronic health record EHR which contains data regarding health status and recent test results for evaluation of renal function
Eligible patients will be presented to the guideline-recommendations for preventive treatment with IV hydration along with blood sampling for evaluation of their renal function seven days prior to the IV CECT at the time of the scheduling of their IV CECT according to normal routine at Odense University Hospital Furthermore the patients will be presented with a short introduction to this study If the patient is interested heshe will be contacted by the lead investigators after which a verbal consent to participate in the study is obtained approximately seven to 14 days prior to the scheduled IV CECT
After the verbal consent is given the guideline-required evaluation of renal function seven days prior to their IV CECT will be planned along with an additional blood sample to evaluate the renal function one-three days prior to their IV CECT Furthermore blood samples to evaluate renal function will be planned at two-three days four-five days and 30 days after IV CECT along with follow-up consultations four-five days and 30 days after IV CECT
A thorough presentation of the study-information will be given by one of the lead investigators at baseline while the patient has been informed about the possibility of bringing an assessor of their choice The information will be delivered in a quiet room which is solely used to deliver patient information The lead investigators will make sure that the presentation is given within a reasonable timeframe prior to their scheduled IV CECT
During the presentation of the study the patient will be informed of the purpose of the study and the written patient information will be sent via e-mail or physically handed to the patient if desired Patients will be given as much time as wanted to decide if they wish to participate in the study after the oral information has been given Patients will be offered the possibility to call or physically meet with one of the lead investigators in case of additional questions before signing the informed consent
Subjects can leave the study at any time for any reason if they wish to do so without any clinical consequences Signed informed consent will be provided prior to any research procedures A subject is considered enrolled in the study once the subject is randomized
Patient data from EHR will be obtained according to the REDCap-database and the study endpoints after the verbal consent is delivered
Participant retention follow-up and withdrawal
Once a patient is enrolled and randomized the research group will make every reasonable effort to follow the patient for the entire study period If the patient fails to attend their appointment for blood sampling to evaluate renal function the patient will be contacted by telephone and a new appointment for blood sampling is scheduled within the next 24 hours The patient will only be excluded from the study after randomization if the patient does not receive the preventive treatment according to the randomization or if the IV CECT is cancelled after randomization and preventive treatment The rate of loss-to-follow-up for the primary and secondary outcomes are expected to be 10
Variables
Standard blood parameters to evaluate renal function will be obtained 90 days seven days one-three days and at baseline prior to the scheduled IV CECT Furthermore an urine sample for albuminecreatinine ratio mgg will be obtained at baseline before CM exposure The standard blood parameters will also be obtained two-three days andor four-five days and 25-40 days after the scheduled IV CECT Additional blood sampling to evaluate renal function will be performed at seven days andor 14-21 days after IV CECT if the patient has increasing SCr four-five days after IV CECT consistent with PC-AKI
The standard blood parameters for patients referred for IV CECT consist of the following Hemoglobin mM erythrocytes countL SCr μmolL eGFR mLmin173 m2 albumine μmolL sodium mM and potassium mM
The prospective cohort is followed over a 30-day period for events of dialysis treatment renal adverse events hospitalization due to hydration- or contrast-related sequelae ie symptomatic heart failure arrythmias renal insufficiency hyponatremia or hypernatremia and all-cause mortality
Progression in CKD-symptoms will be obtained from registration of uremic symptoms through a medical interview at baseline and 30 days after IV CECT A trained interviewer will identify any clinical signs of progression in CKD within the 30-day follow-up Progression in CKD is defined as progression in uremic symptoms which consist of the following
- Weight loss loss of appetite cramps nausea vomiting pruritus bruising fatigue peripheral edema impaired consciousness and changes in sense of taste
The medical history medicine use and echocardiography will be obtained at baseline before initiation of the hydration protocol The patient will then tend to their IV CECT
Blood- and urine samples for biomarkers of PC-AKI will be collected before IV CECT and three-four hours after IV CECT
The admission time is defined as the timespan between the start and the completion of the preventive treatment which is registered as date-month-year-hours-minutes
Dates and reasons for hospital admission 90 days before IV CECT will also be registered along with additional contrast exposure within the 30-day follow-up period after the scheduled IV CECT
The following parameters will also be obtained for the subgroup of participants who are referred for a cardiac IV CECT
Estimated coronary artery calcification score CAC-score
Stenosis 50 of the left main coronary artery LM
The grade of stenosis will be analyzed if present in the coronary arteries LM left anterior descending artery LAD left circumflex artery LCx and right coronary artery RCA
Aortic valve calcification AVC and mitral annulus calcification MAC
Calcification Agatson-score of the aorta aorta ascendens arcus aorta and aorta descendens the suprarenal and infrarenal aorta and the renal arteries
The diameter of aorta aorta ascendens arcus aorta aorta descendens and iliac arteries
The size of the left atrium cm2
Safety
An interim analysis will be performed after inclusion of 127 patients to evaluate the primary outcomes and the key secondary outcomes The steering committee will consider terminating the study preliminary if the analyses conclude a significant difference in the incidence of the primary andor the key secondary outcomes between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Danish Data Protection Act | REGISTRY | 2166779 | None |