Acute Kidney InjuryNCT06463964
Predictors of Acute Kidney Injury in Patients With Acute Decompensated Heart Failure in Emergency
An observational study of Acute Kidney Injury and Acute Heart Failure, run by Sohag University at 1 site in Egypt.
Trial summary
Acute Decompensated Heart Failure ADHF is one of the leading causes of hospitalization. ADHF is a growing global health problem affecting more than 26 million individuals worldwide Acute Kidney Injury AKI is a common event in the natural disease history of patients with Heart Failure HF, The clinical importance of the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Acute Heart Failure
- What is being tested?
- Serum Creatinine
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aged >18 Yrs Both Sexes Patients with ADHF
Who may be able to join
- Aged >18 Yrs Both Sexes Patients with ADHF
Who cannot join
- Patients udnergoing maintenance renal replacment therapy (RRT) such as hemodialysis and peritoneal dialysis History of CKD Kdiney transplantation Undergoing opeartions within 1 week before and after AKI events Drug Toxicity Rheumatologic or auto immune disease Acute infection Diretic therapy of radio-opaque contrast media in the last 15 days History of aminoglycosides, metformin and nonsteroid anti inflammatory drugs in the last 7 days Thyroid dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Acute Decompensated Heart Failure ADHF is one of the leading causes of hospitalization. ADHF is a growing global health problem affecting more than 26 million individuals worldwide Acute Kidney Injury AKI is a common event in the natural disease history of patients with Heart Failure HF, The clinical importance of the co-existence of acute cardiac and renal dysfunction, known as acute cardiorenal syndrome CRS, and its management have recieved great attention recently Various studies have employed different criteria to define and calssify AKI. According to Risk, Injury, and Failure; and Loss, and End-stage kidney disease RIFLE criteria formulated by the Acute Dialyisis Quality Initiative ADQI AKI can be divided into five stages; renal injury risk, renal impairment, renal failure, renal function loss, and end stage kidney disease
Read the detailed description
In the past few years, investigators have reported that AHF patients might experience "congestion", named to describe signs and symptoms of extracellular fluid accumulation that results in increased cardiac filling pressure. This triggers compensatory mechanisms such as the renin-angiotensin-aldosterone system, sympathetic nervous system, and other local mediators. These compensatory mechanisms interact to maintain fluid volume and "renal congestion" has been recognized as part of systemic congestion. Renal congestion, resulting from lower cardiac output, tubule glomerular feedback, increased intra-abdominal pressure and increased venous pressure, has been viewed as a contributor to renal function impairment in ADHF.
Most patients with acute CRS are treated in the emergency department ED. The findings provide important insight into the present situation of patients with ADHF who develop AKI in an emergency setting.
The current diagnostic paradigm for AKI relies largely on biomarkers of renal function (serum creatinine and urine output) that have been in clinical use for over 50 years but are known to be insensitive and slow to change after kidney injury . It is very important to detect kidney damage in the preclinical process with new diagnostic methods and thus to provide early intervention in AKI.
Changing AKI definition and classification by year, these existing prediction models also vary by population, region, sample size and research methods. However, many studies have found a high incidence of AKI and a large impact on outcomes in ADHF patients, data pooled from these studies are inadequate. So, we will conduct this study to evaluate predictors of AKI in patients with ADHF in emergency departments.
- Conditions
- Acute Kidney Injury, Acute Heart Failure
- Being tested
- Serum Creatinine
- 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 CreatinineDiagnostic test
Also called CBC, Estimated GFR, Lipid profile, Serum electrolytes
Laborataries for prediction of AKi in patients with ADHF
| Study group | Role | What they receive |
|---|---|---|
| Group I | ( Patients with worsening ADHF) Receives: Diagnostic Test: Serum Creatinine | |
| Group II | (Patients with new (de novo ) ADHF) Receives: Diagnostic Test: Serum Creatinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum creatinine in mg/dL in patients with acute decompensated heart failure in ER
Change in serum creatinine in patients with acute decompensated heart failure in ER
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Medhat Farouk, Sohag University
- Investigators
- Magdy M Amin, Professor, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463964
- Sponsor's protocol ID
- Soh-Med-24-05-17MS
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Afsar B, Ortiz A, Covic A, Solak Y, Goldsmith D, Kanbay M. Focus on renal congestion in heart failure. Clin Kidney J. 2016 Feb;9(1):39-47. doi: 10.1093/ckj/sfv124. Epub 2015 Nov 29.
PubMed 26798459Chahal RS, Chukwu CA, Kalra PR, Kalra PA. Heart failure and acute renal dysfunction in the cardiorenal syndrome. Clin Med (Lond). 2020 Mar;20(2):146-150. doi: 10.7861/clinmed.2019-0422.
PubMed 32188648Chen JJ, Lee TH, Kuo G, Yen CL, Chen SW, Chu PH, Fan PC, Chien-Chia Wu V, Chang CH. Acute Kidney Disease After Acute Decompensated Heart Failure. Kidney Int Rep. 2022 Jan 3;7(3):526-536. doi: 10.1016/j.ekir.2021.12.033. eCollection 2022 Mar.
PubMed 35257065Fuhrman DY, Stanski NL, Krawczeski CD, Greenberg JH, Arikan AAA, Basu RK, Goldstein SL, Gist KM; ADQI 26 workgroup. A proposed framework for advancing acute kidney injury risk stratification and diagnosis in children: a report from the 26th Acute Disease Quality Initiative (ADQI) conference. Pediatr Nephrol. 2024 Mar;39(3):929-939. doi: 10.1007/s00467-023-06133-3. Epub 2023 Sep 5.
PubMed 37670082
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Acute Kidney Injury in Patients With Acute Decompensated Heart Failure in Emergency
- ClinicalTrials.gov ID
- NCT06463964
- Acronym / sponsor ID
- Soh-Med-24-05-17MS
- Conditions
- Acute Kidney Injury, Acute Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Jun 2024 (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.
Acute Decompensated Heart Failure ADHF is one of the leading causes of hospitalization. ADHF is a growing global health problem affecting more than 26 million individuals worldwide Acute Kidney Injury AKI is a common event in the natural disease history of patients with Heart Failure HF, The clinical importance of the co-existence of acute cardiac and renal dysfunction, known as acute cardiorenal syndrome CRS, and its management have recieved great attention recently Various studies have employed different criteria to define and calssify AKI. According to Risk, Injury, and Failure; and Loss, and End-stage kidney disease RIFLE criteria formulated by the Acute Dialyisis Quality Initiative ADQI AKI can be divided into five stages; renal injury risk, renal impairment, renal failure, renal function loss, and end stage kidney disease
Detailed description
In the past few years, investigators have reported that AHF patients might experience "congestion", named to describe signs and symptoms of extracellular fluid accumulation that results in increased cardiac filling pressure. This triggers compensatory mechanisms such as the renin-angiotensin-aldosterone system, sympathetic nervous system, and other local mediators. These compensatory mechanisms interact to maintain fluid volume and "renal congestion" has been recognized as part of systemic congestion. Renal congestion, resulting from lower cardiac output, tubule glomerular feedback, increased intra-abdominal pressure and increased venous pressure, has been viewed as a contributor to renal function impairment in ADHF.
Most patients with acute CRS are treated in the emergency department ED. The findings provide important insight into the present situation of patients with ADHF who develop AKI in an emergency setting.
The current diagnostic paradigm for AKI relies largely on biomarkers of renal function (serum creatinine and urine output) that have been in clinical use for over 50 years but are known to be insensitive and slow to change after kidney injury . It is very important to detect kidney damage in the preclinical process with new diagnostic methods and thus to provide early intervention in AKI.
Changing AKI definition and classification by year, these existing prediction models also vary by population, region, sample size and research methods. However, many studies have found a high incidence of AKI and a large impact on outcomes in ADHF patients, data pooled from these studies are inadequate. So, we will conduct this study to evaluate predictors of AKI in patients with ADHF in emergency departments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Serum Creatinine( Patients with worsening ADHF) |
| Group II | – | Diagnostic Test: Serum Creatinine(Patients with new (de novo ) ADHF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aged >18 Yrs Both Sexes Patients with ADHF
Key inclusion criteria (1 listed)
- Aged >18 Yrs Both Sexes Patients with ADHF
Key exclusion criteria (1 listed)
- Patients udnergoing maintenance renal replacment therapy (RRT) such as hemodialysis and peritoneal dialysis History of CKD Kdiney transplantation Undergoing opeartions within 1 week before and after AKI events Drug Toxicity Rheumatologic or auto immune disease Acute infection Diretic therapy of radio-opaque contrast media in the last 15 days History of aminoglycosides, metformin and nonsteroid anti inflammatory drugs in the last 7 days Thyroid dysfunction
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 CreatinineAlso: CBC, Estimated GFR, Lipid profile, Serum electrolytesLaborataries for prediction of AKi in patients with ADHF | Diagnostic test | Group I, Group II |
Primary outcome
Change in serum creatinine in mg/dL in patients with acute decompensated heart failure in ER
Time frame: 6 months
Change in serum creatinine in patients with acute decompensated heart failure in ER
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 26798459Afsar B, Ortiz A, Covic A, Solak Y, Goldsmith D, Kanbay M. Focus on renal congestion in heart failure. Clin Kidney J. 2016 Feb;9(1):39-47. doi: 10.1093/ckj/sfv124. Epub 2015 Nov 29.
- Background: PubMed 32188648Chahal RS, Chukwu CA, Kalra PR, Kalra PA. Heart failure and acute renal dysfunction in the cardiorenal syndrome. Clin Med (Lond). 2020 Mar;20(2):146-150. doi: 10.7861/clinmed.2019-0422.
- Background: PubMed 35257065Chen JJ, Lee TH, Kuo G, Yen CL, Chen SW, Chu PH, Fan PC, Chien-Chia Wu V, Chang CH. Acute Kidney Disease After Acute Decompensated Heart Failure. Kidney Int Rep. 2022 Jan 3;7(3):526-536. doi: 10.1016/j.ekir.2021.12.033. eCollection 2022 Mar.
- Background: PubMed 37670082Fuhrman DY, Stanski NL, Krawczeski CD, Greenberg JH, Arikan AAA, Basu RK, Goldstein SL, Gist KM; ADQI 26 workgroup. A proposed framework for advancing acute kidney injury risk stratification and diagnosis in children: a report from the 26th Acute Disease Quality Initiative (ADQI) conference. Pediatr Nephrol. 2024 Mar;39(3):929-939. doi: 10.1007/s00467-023-06133-3. Epub 2023 Sep 5.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Magdy M Amin, Professor principal investigator
Sohag University
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 and Acute Heart Failure, run by Sohag 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 18 Jun 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum creatinine in mg/dL in patients with acute decompensated heart failure in ER (time frame: 6 months). 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 NCT06463964, which also lists 4 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 18 Jun 2024.