NCT03369561

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

November 25, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

November 25, 2017

Last Update Submit

December 10, 2017

Conditions

Acute Kidney Injury (Nontraumatic)

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Study Arms (1)

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

Diagnostic Test: Serum urea and creatinine and the calculated e GFR

Interventions

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

normal cardiac patient

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All pt admitted to ICU with Lt , Rt or Bi ventricular dysfunction That develops AKI

You may qualify if:

  • cardiac patient

You may not qualify if:

  • ESRD pt CKD Cirrhotic patients AKI due to post renal cause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Assiut University71515, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 24810531BACKGROUND

  • 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.

    PMID: 18158481BACKGROUND

  • 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.

    PMID: 23254894BACKGROUND

  • 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.

    PMID: 23499048BACKGROUND

  • 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.

    PMID: 19433995BACKGROUND

  • 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.

    PMID: 25690125BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ashraf M El-Shazly, Prof

    Assiut

    STUDY CHAIR

Central Study Contacts

Ahmed A Obiedallah, lecture

CONTACT

00201007556396ahmed_obiedallah@yahoo.com

Noura G Nasr, RD

CONTACT

00201096137766noura.victory@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle Investigator

Study Record Dates

First Submitted

November 25, 2017

First Posted

December 12, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2020

Last Updated

December 12, 2017

Record last verified: 2017-12

Locations

EG(1)