- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348510
Diuretic Effect of Aminophylline and Furosemide in Adult Patients Undergoing Cardiac Surgical Procedures
Comparison Between the Diuretic Effect of Aminophylline and Furosemide in Adult Patients Undergoing Cardiac Surgical Procedures: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Acute Kidney injury (AKI) is a serious and common complication after either adult or pediatric cardiac surgery.
The results of a recent meta-analysis suggested that loop diuretics (furosemide) may reduce postoperative creatinine clearance, whereas aldosterone agonists (spironolactone) increase the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI). Diuretics are not recommended for the prevention of AKI, but loop diuretics may be used for the management of volume overload Aminophylline in cardiac surgery can reduce the frequency of AKI and could be used in the prevention of AKI as a safe and efficient modality in high-risk patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed M Hassan, MSc
- Phone Number: 00201033752020
- Email: ahm33hassan@gmail.com
Study Locations
-
-
-
Cairo, Egypt, 12613
- Recruiting
- Cairo University
-
Contact:
- Ahmed M Hassan, MSc
- Phone Number: 00201033752020
- Email: ahm33hassan@gmail.com
-
Sub-Investigator:
- Maged Salah, MD
-
Sub-Investigator:
- Pierre Zarif, MD
-
Sub-Investigator:
- Maged Abdel Waha, MD
-
Sub-Investigator:
- Sherif Mamdouh, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 18-65 years.
- Both sexes.
- All adult patients presenting for elective cardiac surgical procedures performed on cardiopulmonary bypass (Coronary artery bypass surgery, Cardiac valve repair and/or replacement, Repair of large septal defects, Repair and/or palliation of congenital heart defects, Transplantation, surgery of thoracic aneurysms.).
- Body mass index (BMI) ranged between 20 and 40 kg/m2.
Exclusion Criteria:
- Sensitivity or contraindication to Aminophylline or furosemide
- Stage-5 chronic kidney disease (CKD) [Glomerular filtration rate (GFR) of less than 15 mL/min].
- The presence of both factors (GFR less than 60 mL/min and albumin greater than 30 mg per gram of creatinine) along with abnormalities of kidney structure or function for greater than three months signifies chronic kidney disease.
- Recipients of dialysis before surgery.
- Recipients of solid-organ transplantation before surgery.
- Emergency cardiac surgical procedures (e.g. left main coronary artery bypass graft, stuck valves, etc).
- Patient refusal.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Aminophylline group (control group)
Patients will receive Aminophylline.
|
Patients will receive Aminophylline.
|
|
Experimental: Furosemide group
Patients will receive furosemide.
|
Patients will receive furosemide.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of urine output
Time Frame: Two hours after cardiopulmonary bypass
|
Urine output will be measured at two hours after cardiopulmonary bypass.
|
Two hours after cardiopulmonary bypass
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of urine output at completion of cardiopulmonary bypass
Time Frame: 48 hours after cardiopulmonary bypass
|
Urine output at completion of cardiopulmonary bypass (CPB) will be measured at 8 hours and 48 hours after CPB.
|
48 hours after cardiopulmonary bypass
|
|
Urea level
Time Frame: 48 hours after cardiopulmonary bypass
|
Urea level will be measured at 8 hours and 48 hours after cardiopulmonary bypass.
|
48 hours after cardiopulmonary bypass
|
|
Creatinine level
Time Frame: 48 hours after cardiopulmonary bypass
|
Creatinine level will be measured at 8 hours and 48 hours after cardiopulmonary bypass.
|
48 hours after cardiopulmonary bypass
|
|
Lactate level
Time Frame: 48 hours after cardiopulmonary bypass
|
Lactate level will be measured at 8 hours and 48 hours after cardiopulmonary bypass.
|
48 hours after cardiopulmonary bypass
|
|
Estimated Glomerular Filtration Rate (eGFR)
Time Frame: 48 hours after cardiopulmonary bypass
|
Estimated Glomerular Filtration Rate (eGFR) at completion of cardiopulmonary bypass (CPB) will be measured at 8 hours and 48 hours after CPB.
|
48 hours after cardiopulmonary bypass
|
|
Measurement of fluid balance
Time Frame: 48 hours after cardiopulmonary bypass
|
Fluid balance at completion of cardiopulmonary bypass (CPB) will be measured at 8 hours and 48 hours after CPB.
|
48 hours after cardiopulmonary bypass
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Pharmaceutical Preparations
- Amides
- Aniline Compounds
- Amines
- Purinones
- Purines
- Drug Combinations
- Sulfonamides
- Sulfanilamides
- Sulfones
- Ethylenediamines
- Diamines
- Polyamines
- Xanthines
- Theophylline
- Furosemide
- Aminophylline
Other Study ID Numbers
- MD-258-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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