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NCT Number: NCT04292262

Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

Acute Kidney Injury (AKI) is a common complication of severe trauma patients and is associated with increased morbidity and mortality.Trauma patients have many risk factors for AKI such as hypovolemic shock, rhabdomyolysis, massive transfusion, major surgeries and abdominal compartment syndrome.The primary outcome of the study is to correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS .The secondary outcomes are ;the length of ICU and hospital stay and 28 days mortality in AKI patients.

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Key information

Conditions

AKI (Acute Kidney Injury) Due to Trauma Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

About this study

  • Study Population: 60 cases of polytrauma patients who have ISS>15.
  • Inclusion Criteria:
  • Age from 18 to 70 years old males or females
  • Injury Sensitivity Score (ISS >15 )
  • Exclusion Criteria:

Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.

Sample size :the calculated sample size is 60 cases of trauma patients.

  • All patients' data will be recorded on admission and daily for 7 days:
  • Vital signs (blood pressure, heart rate, respiratory rate, body temperature).
  • Lab investigations: complete blood count, international normalized ratio, prothrombin time, arterial blood gases, kidney function tests, liver function tests, creatine kinase, creatine kinase-muscle band, creatinine clearance, serum sodium, serum potassium and serum phosphorus will be requested for all patients at admission then daily follow up by creatine kinase, creatine kinase-muscle band, kidney function tests, serum sodium, serum potassium and serum phosphorus for 7 days. Glasgow Coma Scale (GCS), Injury Severity Score (ISS),Urine output (ml/kg/h),RIFLE criteria.,Length of ICU and hospital stay,28 days mortality.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Age from 18 to 70 years old males or females
  • Injury Sensitivity Score (ISS >15 )

Exclusion criteria

  • Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS

    Time frame: 7 days

Secondary outcomes

  1. the length of ICU and hospital stay and 28 days mortality in AKI patients.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

A Prospective Observational Study on the Incidence of Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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