AKI (Acute Kidney Injury) Due to TraumaNCT04292262
Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit
An observational study of AKI (Acute Kidney Injury) Due to Trauma, run by Ain Shams University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AKI (Acute Kidney Injury) Due to Trauma
- What is being tested?
- Observational
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 30 Aug 2020
- How long will I take part?
- 4 Months
- 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 70 years
- All sexes
- Adult, Older adult
Study population: a prospective observational cohort study.
Who may be able to join
- • Age from 18 to 70 years old males or females
- Injury Sensitivity Score (ISS >15 )
Who cannot join
- Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study on the Incidence of 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.
Read the detailed description
- 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.
- Conditions
- AKI (Acute Kidney Injury) Due to Trauma
- Being tested
- Observational
- 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.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| AKI | Not described Receives: Other: Observational | |
| Non AKI | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS
Measured: 7 days
Secondary outcomes (1)
the length of ICU and hospital stay and 28 days mortality in AKI patients.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 May 2020
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI (Acute Kidney Injury) Due to TraumaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292262
- Sponsor's protocol ID
- FMASU M S 289/2020
- Status last verified
- Oct 2020
- First submitted
- 28 Feb 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Incidence of Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04292262
- Acronym / sponsor ID
- FMASU M S 289/2020
- Conditions
- AKI (Acute Kidney Injury) Due to Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 3 Mar 2020 (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 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.
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI | – | Other: Observational |
| Non AKI | – | Other: Observational |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- a prospective observational cohort study.
Key inclusion criteria (2 listed)
- • Age from 18 to 70 years old males or females
Key exclusion criteria (1 listed)
- Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.
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 |
|---|---|---|
| ObservationalObservational | Other | AKI, Non AKI |
Primary outcome
Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS
Time frame: 7 days
1 secondary outcome
the length of ICU and hospital stay and 28 days mortality in AKI patients.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AKI (Acute Kidney Injury) Due to Trauma, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2020.