Acute Kidney Injury (Nontraumatic)NCT03369561
Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for Aki in Critical Care Patients
An observational study of Acute Kidney Injury (Nontraumatic), run by Assiut University at 1 site in Egypt.
Trial summary
The cardio renal syndrome generally focuses on left ventricular function, and the importance of the right ventricle as a determinant of renal function is described less frequently. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic)
- What is being tested?
- Serum urea and creatinine and the calculated e GFR
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pt admitted to ICU with Lt , Rt or Bi ventricular dysfunction That develops AKI
Who may be able to join
- cardiac patient
Who cannot join
- ESRD pt CKD Cirrhotic patients AKI due to post renal cause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for AKI in Critical Care Patients
The cardio renal syndrome generally focuses on left ventricular function, and the importance of the right ventricle as a determinant of renal function is described less frequently. Although the risk of AKI is similar for patients with isolated LVD and isolated RVD, the severity of AKI and the associated risk of hospital mortality is highest among those with isolated RVD.
Read the 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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- Conditions
- Acute Kidney Injury (Nontraumatic)
- Being tested
- Serum urea and creatinine and the calculated e GFR
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum urea and creatinine and the calculated e GFRDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Serum urea and creatinine and the calculated e GFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI during the 1st 7 days of ICU care,
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura gamal, Assiut University
- Investigators
- Ashraf M El-Shazly, Prof, Study chair, Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369561
- Sponsor's protocol ID
- CBRALVSDASRFFAKICCP
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 24810531Liang 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.
PubMed 18158481F 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.
PubMed 23254894Palevsky 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.
PubMed 23499048van 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.
PubMed 19433995Gutacker 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.
PubMed 25690125
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for AKI in Critical Care Patients
- ClinicalTrials.gov ID
- NCT03369561
- Acronym / sponsor ID
- CBRALVSDASRFFAKICCP
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cardio renal syndrome generally focuses on left ventricular function, and the importance of the right ventricle as a determinant of renal function is described less frequently. Although the risk of AKI is similar for patients with isolated LVD and isolated RVD, the severity of AKI and the associated risk of hospital mortality is highest among those with isolated RVD.
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.
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal cardiac patient | – | Diagnostic Test: Serum urea and creatinine and the calculated e GFRFull 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pt admitted to ICU with Lt , Rt or Bi ventricular dysfunction That develops AKI
Key inclusion criteria (1 listed)
- cardiac patient
Key exclusion criteria (1 listed)
- ESRD pt CKD Cirrhotic patients AKI due to post renal cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum urea and creatinine and the calculated e GFRThe 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 | Diagnostic test | normal cardiac patient |
Primary outcome
AKI during the 1st 7 days of ICU care,
Time frame: One year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Background: PubMed 24810531Legrand 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.
- Background: PubMed 18158481Liang 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.
- Background: PubMed 23254894F 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.
- Background: PubMed 23499048Palevsky 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.
- Background: PubMed 19433995van 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.
- Background: PubMed 25690125Gutacker 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf M El-Shazly, Prof study chair
Assiut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury (Nontraumatic), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Obiedallah, lecture (00201007556396, ahmed_obiedallah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI during the 1st 7 days of ICU care, (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369561, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.