- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03369561
Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for Aki in Critical Care Patients
Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for AKI in Critical Care Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The right ventricle seems to affect renal function through different mechanisms, including Venous Congestion, tricuspid regurgitation, And potential inhibitory effect on left ventricular function The most important mechanism is venous congestion, a manifestation of sodium avidity and fluid expansion, as Directly increasing renal venous pressure causes sodium retention, lowers urinary output, and decreases glomerular filtration and widely thought to explain AKI Venous pressure is directly associated with renal dysfunction, independently of ventricular function, and admission peripheral edema is associated with greater risk of AKI. Such awareness of a primary role of renal venous congestion reshapes our understanding of renal function as not simply a reflection of arterial perfusion, but rather a balance between arterial supply and venous drainage.
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Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Assiut, Egypt, Assiut university71515
- Assiut University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- cardiac patient
Exclusion Criteria:
- ESRD pt CKD Cirrhotic patients AKI due to post renal cause
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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normal cardiac patient
Full history and clinical examination ECG on the left and right side Echocardiography and measurement of both left and right ventricular functions Laboratory investigation including cardiac enzymes, CK, CK MB, and cardiac troponin I. Serum urea and creatinine and the calculated e GFR |
The primary outcome will be AKI during the 1st 7 days of ICU care, as defined by an increase of ≥ 0.3 mg/dl in serum creatinine within 48 hours of ICU admission, an increase of ≥ 50% within 7 days of ICU admission, or acute dialysis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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AKI during the 1st 7 days of ICU care,
Time Frame: One year
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defined by an increase of ≥ 0.3 mg/dl in serum creatinine within 48 hours of ICU admission, an increase of ≥ 50% within 7 days of ICU admission, or acute dialysis, in keeping with the Kidney Disease Improving Global Outcomes guidelines.
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One year
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ashraf M El-Shazly, Prof, Assiut
Publications and helpful links
General Publications
- Legrand M, Mebazaa A, Ronco C, Januzzi JL Jr. When cardiac failure, kidney dysfunction, and kidney injury intersect in acute conditions: the case of cardiorenal syndrome. Crit Care Med. 2014 Sep;42(9):2109-17. doi: 10.1097/CCM.0000000000000404.
- Liang KV, Williams AW, Greene EL, Redfield MM. Acute decompensated heart failure and the cardiorenal syndrome. Crit Care Med. 2008 Jan;36(1 Suppl):S75-88. doi: 10.1097/01.CCM.0000296270.41256.5C.
- F Gnanaraj J, von Haehling S, Anker SD, Raj DS, Radhakrishnan J. The relevance of congestion in the cardio-renal syndrome. Kidney Int. 2013 Mar;83(3):384-91. doi: 10.1038/ki.2012.406. Epub 2012 Dec 19.
- Palevsky PM, Liu KD, Brophy PD, Chawla LS, Parikh CR, Thakar CV, Tolwani AJ, Waikar SS, Weisbord SD. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for acute kidney injury. Am J Kidney Dis. 2013 May;61(5):649-72. doi: 10.1053/j.ajkd.2013.02.349. Epub 2013 Mar 15.
- van Walraven C, Austin PC, Jennings A, Quan H, Forster AJ. A modification of the Elixhauser comorbidity measures into a point system for hospital death using administrative data. Med Care. 2009 Jun;47(6):626-33. doi: 10.1097/MLR.0b013e31819432e5.
- Gutacker N, Bloor K, Cookson R. Comparing the performance of the Charlson/Deyo and Elixhauser comorbidity measures across five European countries and three conditions. Eur J Public Health. 2015 Feb;25 Suppl 1:15-20. doi: 10.1093/eurpub/cku221.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Other Study ID Numbers
- CBRALVSDASRFFAKICCP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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