NCT05242705

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

February 7, 2022

Last Update Submit

February 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 years

Interventions

collection of serum samples for chemical analysis

Also known as: Serum Cystatin C

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 26243789BACKGROUND
  • Zhang 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.

    PMID: 21601330BACKGROUND
  • Shlipak 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.

    PMID: 23701892BACKGROUND
  • Mosa 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.

    PMID: 26982887BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Heba Ahmed Abd El Hafeez, Professor

CONTACT

Tahera Mohammed Kamel, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 16, 2022

Study Start

March 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 8, 2022

Record last verified: 2022-02