NCT03902483

Brief Summary

Acute kidney injury is a common complication of critical illness and is associated with high morbidity and mortality .Acute kidney injury is a syndrome that is characterized by a rapid decline in renal function and urine output, resulting in retention of waste products such as urea, nitrogen, and serum creatinine. Life-threatening consequences include volume overload, hyperkalaemia, and metabolic acidosis . In its severe form, Acute kidney injury requires renal replacement therapy, which is applied in 5±13% of Intensive Care Unit patients

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

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

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 2, 2019

Last Update Submit

April 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Role of Doppler Renal resistative index in early Prediction of acute kidney injury in critically ill patients

    Renal resistive index was measured with ultrasound-Doppler using atransparietal 5MHz pulsed-wave Doppler probe. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive Doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney.The median value of each section will be used and the 3 median values of each kidney will be averaged. patients developing AKI would have an AKI of 0.79 with a standard deviation of 0.11

    at one day of the study

Interventions

renal doppler ultrasound measuring renal resistive index

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

80 patients of critically ill patients including acute ischaemic insults, patients presenting with septicaemia, hypertension, respiratory failure, coagulation/ haemorrhagic disorders, shock, and liver diseasea and shock. This study will be performed in the 24-bed mixed medical and surgical intensive care unit of the Assiut University Hospital. Sample size calculations will be based on the assumption that patients not developing Acute Kidney Injury would have an RRI of 0.72 and patients developing Acute Kidney Injury would have an Acute Kidney Injury of 0.79 with a standard deviation of 0.11. These calculations were based on the results of other previous studies that reported median values for Acute Kidney Injury and no Acute Kidney Injury

You may qualify if:

  • age \>18 years ICU admission within 24 hours

You may not qualify if:

  • Poor abdominal echogenicity
  • Severe acute or chronic renal insufficiency
  • Dialysis dependency, renal transplantation
  • Renal artery stenosis, congenital renal diseases ,renal tumor
  • Suicidal attempt
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012 Aug 25;380(9843):756-66. doi: 10.1016/S0140-6736(11)61454-2. Epub 2012 May 21.

    PMID: 22617274BACKGROUND
  • Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.

    PMID: 26162677BACKGROUND
  • Hilton R. Acute renal failure. BMJ. 2006 Oct 14;333(7572):786-90. doi: 10.1136/bmj.38975.657639.AE. No abstract available.

    PMID: 17038736BACKGROUND
  • Basile DP, Anderson MD, Sutton TA. Pathophysiology of acute kidney injury. Compr Physiol. 2012 Apr;2(2):1303-53. doi: 10.1002/cphy.c110041.

    PMID: 23798302BACKGROUND
  • Gomez H, Ince C, De Backer D, Pickkers P, Payen D, Hotchkiss J, Kellum JA. A unified theory of sepsis-induced acute kidney injury: inflammation, microcirculatory dysfunction, bioenergetics, and the tubular cell adaptation to injury. Shock. 2014 Jan;41(1):3-11. doi: 10.1097/SHK.0000000000000052.

    PMID: 24346647BACKGROUND
  • Spatola L, Andrulli S. Doppler ultrasound in kidney diseases: a key parameter in clinical long-term follow-up. J Ultrasound. 2016 Apr 16;19(4):243-250. doi: 10.1007/s40477-016-0201-x. eCollection 2016 Dec.

    PMID: 27965714BACKGROUND
  • Leoncini G, Martinoli C, Viazzi F, Ravera M, Parodi D, Ratto E, Vettoretti S, Tomolillo C, Derchi LE, Deferrari G, Pontremoli R. Changes in renal resistive index and urinary albumin excretion in hypertensive patients under long-term treatment with lisinopril or nifedipine GITS. Nephron. 2002 Feb;90(2):169-73. doi: 10.1159/000049038.

    PMID: 11818701BACKGROUND

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

  • abdalla ismael

    Dr.

    STUDY DIRECTOR

Central Study Contacts

manar salah, resident

CONTACT

marwa kamal, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiut University

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

July 1, 2019

Primary Completion

June 30, 2020

Study Completion

December 1, 2021

Last Updated

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share