Acute Kidney InjuryNCT05242705
Serum Cysteine Rich Protein 61 and Cystatin C for Early Detection of Acute Kidney Injury in Patients With Heart Diseases
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
Acute Kidney Injury (AKI) is defined as an absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), a percentage increase in serum creatinine ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours) S.creatinine which is considered the gold standard… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Serum Cysteine Rich Protein 61
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 31 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient come to assuit university hospital with typical chest pain, ECG changes, Echocardiogram positive finding then develope absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), with percentage increase in serum creatinine ≥50% (1.5-fold from baseline) or with reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours)
Who may be able to join
- Age ≥ 18 years.
- Informed consent
- Patient with absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l) or with percentage increase in serum creatinine ≥50% (1.5-fold from baseline)
- Patient with reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours)
- Patient with typical chest pain, ECG changes, Echocardiogram positive finding
Who cannot join
- History of nephrectomy
- patient with renal transplantation
- patient with renal replacement therapy initiated before admission
- patient with chronic kidney disease
- patient on regular haemodialysis
- patient known to be diabetic
Trial locations and contacts
No sites are listed yet.
Tahera Mohammed Kamel, Professor contact
About this study
Official title: Serum Cysteine Rich Protein 61 and Cystatin C for Early Detection of Acute Kidney Injury in Patients With Acute Coronary Syndromes
Acute Kidney Injury (AKI) is defined as an absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), a percentage increase in serum creatinine ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours) S.creatinine which is considered the gold standard currently for diagnosis of AKI remains unchanged until 50% of kidney function falls down. It is affected by non-specific factors like diet, age, dehydration, muscle mass, gender, and drugs.
There were evidences of the association between AKI and acute coronary syndrome (ACS); First, AKI detection may be missed by cardiologists. Physicians tend to disregard mild or transient serum creatinine elevation during hospital stay for ACS, and they often attribute small serum creatinine increases to laboratory variations.
Read the detailed description
Cystatin C (CysC), a cystatin protease inhibitor, is less affected by non-specific factors. When glomerular filtration rate (GFR) decreases, CysC begins to increase.
CysC was recommended to be measured in addition to creatinine in GFR estimation.
Cysteine-rich protein 61 (Cyr61) is a cysteine-rich secretory protein that promotes cell proliferation, adhesion, chemotaxis, embryonic development and neovascularization . Previous studies have detected low expression level of Cyr61 in normal adult kidney and high expression of Cyr61 in ischemic rats and mice kidney, which suggests that Cyr61 may be a potential biomarker for diagnosis of AKI . CYR61 might possibly identify patients with more severe kidney injury, which would be very beneficial for early treatment of AKI after
- Conditions
- Acute Kidney Injury
- Being tested
- Serum Cysteine Rich Protein 61
- 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 Cysteine Rich Protein 61Diagnostic test
Also called Serum Cystatin C
collection of serum samples for chemical analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of acute kidney injury in patient with acute coronary syndromes after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)
Early detection of acute kidney injury in patient with acute coronary syndromes after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 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 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrook S. Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242705
- Sponsor's protocol ID
- SHSAS
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marenzi G, Cosentino N, Bartorelli AL. Acute kidney injury in patients with acute coronary syndromes. Heart. 2015 Nov;101(22):1778-85. doi: 10.1136/heartjnl-2015-307773. Epub 2015 Aug 4.
PubMed 26243789Zhang Z, Lu B, Sheng X, Jin N. Cystatin C in prediction of acute kidney injury: a systemic review and meta-analysis. Am J Kidney Dis. 2011 Sep;58(3):356-65. doi: 10.1053/j.ajkd.2011.02.389. Epub 2011 May 20.
PubMed 21601330Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013 Sep;62(3):595-603. doi: 10.1053/j.ajkd.2013.03.027. Epub 2013 May 20.
PubMed 23701892Mosa OF, Skitek M, Kalisnik JM, Jerin A. Evaluation of serum cysteine-rich protein 61 and cystatin C levels for assessment of acute kidney injury after cardiac surgery. Ren Fail. 2016 Jun;38(5):699-705. doi: 10.3109/0886022X.2016.1157747. Epub 2016 Mar 16.
PubMed 26982887
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Cysteine Rich Protein 61 and Cystatin C for Early Detection of Acute Kidney Injury in Patients With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT05242705
- Acronym / sponsor ID
- SHSAS
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Feb 2022 (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 Kidney Injury (AKI) is defined as an absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), a percentage increase in serum creatinine ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours) S.creatinine which is considered the gold standard currently for diagnosis of AKI remains unchanged until 50% of kidney function falls down. It is affected by non-specific factors like diet, age, dehydration, muscle mass, gender, and drugs.
There were evidences of the association between AKI and acute coronary syndrome (ACS); First, AKI detection may be missed by cardiologists. Physicians tend to disregard mild or transient serum creatinine elevation during hospital stay for ACS, and they often attribute small serum creatinine increases to laboratory variations.
Detailed description
Cystatin C (CysC), a cystatin protease inhibitor, is less affected by non-specific factors. When glomerular filtration rate (GFR) decreases, CysC begins to increase.
CysC was recommended to be measured in addition to creatinine in GFR estimation.
Cysteine-rich protein 61 (Cyr61) is a cysteine-rich secretory protein that promotes cell proliferation, adhesion, chemotaxis, embryonic development and neovascularization . Previous studies have detected low expression level of Cyr61 in normal adult kidney and high expression of Cyr61 in ischemic rats and mice kidney, which suggests that Cyr61 may be a potential biomarker for diagnosis of AKI . CYR61 might possibly identify patients with more severe kidney injury, which would be very beneficial for early treatment of AKI after
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient come to assuit university hospital with typical chest pain, ECG changes, Echocardiogram positive finding then develope absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), with percentage increase in serum creatinine ≥50% (1.5-fold from baseline) or with reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours)
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Informed consent
- Patient with absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l) or with percentage increase in serum creatinine ≥50% (1.5-fold from baseline)
- Patient with reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours)
- Patient with typical chest pain, ECG changes, Echocardiogram positive finding
Key exclusion criteria (6 listed)
- History of nephrectomy
- patient with renal transplantation
- patient with renal replacement therapy initiated before admission
- patient with chronic kidney disease
- patient on regular haemodialysis
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 Cysteine Rich Protein 61Also: Serum Cystatin Ccollection of serum samples for chemical analysis | Diagnostic test | – |
Primary outcome
Early detection of acute kidney injury in patient with acute coronary syndromes after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)
Time frame: 3 years
Early detection of acute kidney injury in patient with acute coronary syndromes after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 26243789Marenzi G, Cosentino N, Bartorelli AL. Acute kidney injury in patients with acute coronary syndromes. Heart. 2015 Nov;101(22):1778-85. doi: 10.1136/heartjnl-2015-307773. Epub 2015 Aug 4.
- Background: PubMed 21601330Zhang Z, Lu B, Sheng X, Jin N. Cystatin C in prediction of acute kidney injury: a systemic review and meta-analysis. Am J Kidney Dis. 2011 Sep;58(3):356-65. doi: 10.1053/j.ajkd.2011.02.389. Epub 2011 May 20.
- Background: PubMed 23701892Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013 Sep;62(3):595-603. doi: 10.1053/j.ajkd.2013.03.027. Epub 2013 May 20.
- Background: PubMed 26982887Mosa OF, Skitek M, Kalisnik JM, Jerin A. Evaluation of serum cysteine-rich protein 61 and cystatin C levels for assessment of acute kidney injury after cardiac surgery. Ren Fail. 2016 Jun;38(5):699-705. doi: 10.3109/0886022X.2016.1157747. Epub 2016 Mar 16.
- 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.
Tahera Mohammed Kamel, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut University.
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 5 inclusion and 6 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Heba Ahmed Abd El Hafeez, Professor (+201006268407, dr_heba.ahmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of acute kidney injury in patient with acute coronary syndromes after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI) (time frame: 3 years). 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 NCT05242705, 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 8 Mar 2022.