Acute Kidney InjuryNCT06177886
Acute Kidney Injury in Pediatric Polytrauma Patients at Assiut University Trauma Unit: A Cross-Sectional Study on Incidence and Predictive Risk Factors
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
This study aims to investigate the true incidence and clinical presentation of post-traumatic AKI in hospitalized pediatric patients and identify the risk, and severity of AKI. The results would aid the emergency physicians in the early identification of those at risk of AKI to establish a resuscitation strategy that… Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Feb 2025
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: From September 2023 till September 2024, all patients admitted to the emergency department who meet the eligibility criteria will be recruited in this study after obtaining informed consent from their legal guardians.
Who may be able to join
- The present study will be conducted on pediatric patients with multiple traumas of both genders aged 2yr to 18 yr who have no previous history of kidney disease or chronic illness.
Who cannot join
- Patients who are less than 2 years old or more than 18 years old.
- Direct trauma kidney or localized individual trauma
- children with preexisting kidney disease
- children with drug nephrotoxicity
- children underwent renal transplant
- children post-cardiac arrest
- Patients leaving the hospital on the same day or transferred to a different hospital will be excluded from this study.
- Patients refusing the study will be excluded.
About this study
Official title: Incidence and Predictive Risk Factors of Acute Kidney Injury in Pediatric Polytrauma Patients Admitted to Assiut University Trauma Unit: a Cross-sectional Study
This study aims to investigate the true incidence and clinical presentation of post-traumatic AKI in hospitalized pediatric patients and identify the risk, and severity of AKI. The results would aid the emergency physicians in the early identification of those at risk of AKI to establish a resuscitation strategy that aims at preventing AKI
Read the detailed description
Trauma is a leading cause of morbidity and mortality throughout Africa and the leading cause of mortality worldwide for children and young adults (5-29 years of age).
Organ failure, including AKI, is the third leading cause of mortality in trauma patients, after bleeding and brain injuries.
Trauma patients are at risk of AKI caused by renal hypoperfusion (secondary to haemorrhagic shock), rhabdomyolysis, direct renal injury, abdominal compartment syndrome, or the nephrotoxic effects of therapies.
The majority of trauma-based AKI studies worldwide have looked at critically ill adult trauma patients and these report highly variable AKI rates, ranging 1-50%.
Though pediatric trauma studies on AKI are scarce, a California study suggests 13% of pediatric post-traumatic rhabdomyolysis patients experience AKI.
Acute kidney injury (AKI) is described as a spectrum of abruptly compromised renal functions that result in impaired balance of fluid, electrolytes, and waste products. It is recognized as an increasingly common cause of morbidity and mortality in children.
AKI is defined according to The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines as any of the following: increase in serum creatinine by ≥0.3 mg/dL within 48 h; or increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days; or urine volume <0.5ml /kg/ h for 6 hr.
Preventive measures for AKI are currently the mainstay of non-dialytic AKI management. They include the use of a pediatric early warning score for early detection of AKI, preparation to provide for volume resuscitation in patients with hypovolemia related oliguria, and halting the administration of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers in such patients until their volume status is stabilized. Using appropriate nephrotoxic drug doses (i.e., vancomycin and/or contrast media) to reduce harm to the kidneys.
RRT is the most effective way of managing severe AKI. Peritoneal dialysis has shown as an effective adjuvant treatment for achieving a negative fluid balance, decreasing mechanical ventilation duration, and reducing electrolyte disturbances There is currently no specific effective treatment after the occurrence of established AKI Early detection and prevention of AKI is essential.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI in Pediatric Trauma Patients Admitted to ER
Describing the true incidence of AKI in pediatric trauma patients who are admitted to ER.
- Identification of AKI according to the KDIGO guidelines as follows: I. Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or II. Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or III. Urine volume <0.5 mL/kg/hour for six hours
Measured: baseline
timing of AKI in pediatric trauma patients admitted to ER
time period between admission and diagnosis of AKI
Measured: baseline
Secondary outcomes (2)
Risk Identification of AKI in pediatric trauma patients
Identifying risk for AKI as presence of shock and/or rhabdomyolysis. Exposure to nephrotoxic drugs .
Measured: baseline
mortality outcomes of AKI in pediatric trauma patients
The standardized mortality ratio represents the excess mortality and will be calculated using the observed number of lethal cases divided by the predicted number of lethal cases. The observed count will be obtained from the study data. The predicted number will be obtained by implementing the percentage of mortality risk from all the tools used. The individual values of the risk scores will be averaged to represent the study population.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Atef Alsayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177886
- Sponsor's protocol ID
- AKIPPP
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harrois A, Soyer B, Gauss T, Hamada S, Raux M, Duranteau J; Traumabase(R) Group. Prevalence and risk factors for acute kidney injury among trauma patients: a multicenter cohort study. Crit Care. 2018 Dec 18;22(1):344. doi: 10.1186/s13054-018-2265-9.
PubMed 30563549Harrois A, Libert N, Duranteau J. Acute kidney injury in trauma patients. Curr Opin Crit Care. 2017 Dec;23(6):447-456. doi: 10.1097/MCC.0000000000000463.
PubMed 29035925Reilly JP, Anderson BJ, Mangalmurti NS, Nguyen TD, Holena DN, Wu Q, Nguyen ET, Reilly MP, Lanken PN, Christie JD, Meyer NJ, Shashaty MG. The ABO Histo-Blood Group and AKI in Critically Ill Patients with Trauma or Sepsis. Clin J Am Soc Nephrol. 2015 Nov 6;10(11):1911-20. doi: 10.2215/CJN.12201214. Epub 2015 Sep 4.
PubMed 26342043Bagshaw SM, George C, Gibney RT, Bellomo R. A multi-center evaluation of early acute kidney injury in critically ill trauma patients. Ren Fail. 2008;30(6):581-9. doi: 10.1080/08860220802134649.
PubMed 18661407Eriksson M, Brattstrom O, Martensson J, Larsson E, Oldner A. Acute kidney injury following severe trauma: Risk factors and long-term outcome. J Trauma Acute Care Surg. 2015 Sep;79(3):407-12. doi: 10.1097/TA.0000000000000727.
PubMed 26307873Fujinaga J, Kuriyama A, Shimada N. Incidence and risk factors of acute kidney injury in the Japanese trauma population: A prospective cohort study. Injury. 2017 Oct;48(10):2145-2149. doi: 10.1016/j.injury.2017.08.022. Epub 2017 Aug 15.
PubMed 28842286Santos PR, Monteiro DL. Acute kidney injury in an intensive care unit of a general hospital with emergency room specializing in trauma: an observational prospective study. BMC Nephrol. 2015 Mar 19;16:30. doi: 10.1186/s12882-015-0026-4.
PubMed 25885883Talving P, Karamanos E, Skiada D, Lam L, Teixeira PG, Inaba K, Johnson J, Demetriades D. Relationship of creatine kinase elevation and acute kidney injury in pediatric trauma patients. J Trauma Acute Care Surg. 2013 Mar;74(3):912-6. doi: 10.1097/TA.0b013e318278954e.
PubMed 23425757National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577National Clinical Guideline Centre (UK). Acute Kidney Injury: Prevention, Detection and Management Up to the Point of Renal Replacement Therapy [Internet]. London: Royal College of Physicians (UK); 2013 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK247665/
PubMed 25340231Ricci Z, Romagnoli S. Prescription of dialysis in pediatric acute kidney injury. Minerva Pediatr. 2015 Apr;67(2):159-67. Epub 2015 Jan 23.
PubMed 25615028Kwiatkowski DM, Goldstein SL, Cooper DS, Nelson DP, Morales DL, Krawczeski CD. Peritoneal Dialysis vs Furosemide for Prevention of Fluid Overload in Infants After Cardiac Surgery: A Randomized Clinical Trial. JAMA Pediatr. 2017 Apr 1;171(4):357-364. doi: 10.1001/jamapediatrics.2016.4538.
PubMed 28241247Kwiatkowski DM, Menon S, Krawczeski CD, Goldstein SL, Morales DL, Phillips A, Manning PB, Eghtesady P, Wang Y, Nelson DP, Cooper DS. Improved outcomes with peritoneal dialysis catheter placement after cardiopulmonary bypass in infants. J Thorac Cardiovasc Surg. 2015 Jan;149(1):230-6. doi: 10.1016/j.jtcvs.2013.11.040. Epub 2013 Dec 31.
PubMed 24503323Bojan M, Gioanni S, Vouhe PR, Journois D, Pouard P. Early initiation of peritoneal dialysis in neonates and infants with acute kidney injury following cardiac surgery is associated with a significant decrease in mortality. Kidney Int. 2012 Aug;82(4):474-81. doi: 10.1038/ki.2012.172.
PubMed 22622499Webb TN, Goldstein SL. Congenital heart surgery and acute kidney injury. Curr Opin Anaesthesiol. 2017 Feb;30(1):105-112. doi: 10.1097/ACO.0000000000000406.
PubMed 27748669
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predictive Risk Factors of Acute Kidney Injury in Pediatric Polytrauma Patients Admitted to Assiut University Trauma Unit: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06177886
- Acronym / sponsor ID
- AKIPPP
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 20 Dec 2023 (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.
This study aims to investigate the true incidence and clinical presentation of post-traumatic AKI in hospitalized pediatric patients and identify the risk, and severity of AKI. The results would aid the emergency physicians in the early identification of those at risk of AKI to establish a resuscitation strategy that aims at preventing AKI
Detailed description
Trauma is a leading cause of morbidity and mortality throughout Africa and the leading cause of mortality worldwide for children and young adults (5-29 years of age).
Organ failure, including AKI, is the third leading cause of mortality in trauma patients, after bleeding and brain injuries.
Trauma patients are at risk of AKI caused by renal hypoperfusion (secondary to haemorrhagic shock), rhabdomyolysis, direct renal injury, abdominal compartment syndrome, or the nephrotoxic effects of therapies.
The majority of trauma-based AKI studies worldwide have looked at critically ill adult trauma patients and these report highly variable AKI rates, ranging 1-50%.
Though pediatric trauma studies on AKI are scarce, a California study suggests 13% of pediatric post-traumatic rhabdomyolysis patients experience AKI.
Acute kidney injury (AKI) is described as a spectrum of abruptly compromised renal functions that result in impaired balance of fluid, electrolytes, and waste products. It is recognized as an increasingly common cause of morbidity and mortality in children.
AKI is defined according to The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines as any of the following: increase in serum creatinine by ≥0.3 mg/dL within 48 h; or increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days; or urine volume <0.5ml /kg/ h for 6 hr.
Preventive measures for AKI are currently the mainstay of non-dialytic AKI management. They include the use of a pediatric early warning score for early detection of AKI, preparation to provide for volume resuscitation in patients with hypovolemia related oliguria, and halting the administration of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers in such patients until their volume status is stabilized. Using appropriate nephrotoxic drug doses (i.e., vancomycin and/or contrast media) to reduce harm to the kidneys.
RRT is the most effective way of managing severe AKI. Peritoneal dialysis has shown as an effective adjuvant treatment for achieving a negative fluid balance, decreasing mechanical ventilation duration, and reducing electrolyte disturbances There is currently no specific effective treatment after the occurrence of established AKI Early detection and prevention of AKI is essential.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- From September 2023 till September 2024, all patients admitted to the emergency department who meet the eligibility criteria will be recruited in this study after obtaining informed consent from their legal guardians.
Key inclusion criteria (1 listed)
- The present study will be conducted on pediatric patients with multiple traumas of both genders aged 2yr to 18 yr who have no previous history of kidney disease or chronic illness.
Key exclusion criteria (8 listed)
- Patients who are less than 2 years old or more than 18 years old.
- Direct trauma kidney or localized individual trauma
- children with preexisting kidney disease
- children with drug nephrotoxicity
- children underwent renal transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of AKI in Pediatric Trauma Patients Admitted to ER
Time frame: baseline
Describing the true incidence of AKI in pediatric trauma patients who are admitted to ER. a) Identification of AKI according to the KDIGO guidelines as follows: I. Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or II. Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or III. Urine volume <0.5 mL/kg/hour for six hours
timing of AKI in pediatric trauma patients admitted to ER
Time frame: baseline
time period between admission and diagnosis of AKI
2 secondary outcomes
Risk Identification of AKI in pediatric trauma patients
Time frame: baseline
mortality outcomes of AKI in pediatric trauma patients
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 30563549Harrois A, Soyer B, Gauss T, Hamada S, Raux M, Duranteau J; Traumabase(R) Group. Prevalence and risk factors for acute kidney injury among trauma patients: a multicenter cohort study. Crit Care. 2018 Dec 18;22(1):344. doi: 10.1186/s13054-018-2265-9.
- Background: PubMed 29035925Harrois A, Libert N, Duranteau J. Acute kidney injury in trauma patients. Curr Opin Crit Care. 2017 Dec;23(6):447-456. doi: 10.1097/MCC.0000000000000463.
- Background: PubMed 26342043Reilly JP, Anderson BJ, Mangalmurti NS, Nguyen TD, Holena DN, Wu Q, Nguyen ET, Reilly MP, Lanken PN, Christie JD, Meyer NJ, Shashaty MG. The ABO Histo-Blood Group and AKI in Critically Ill Patients with Trauma or Sepsis. Clin J Am Soc Nephrol. 2015 Nov 6;10(11):1911-20. doi: 10.2215/CJN.12201214. Epub 2015 Sep 4.
- Background: PubMed 18661407Bagshaw SM, George C, Gibney RT, Bellomo R. A multi-center evaluation of early acute kidney injury in critically ill trauma patients. Ren Fail. 2008;30(6):581-9. doi: 10.1080/08860220802134649.
- Background: PubMed 26307873Eriksson M, Brattstrom O, Martensson J, Larsson E, Oldner A. Acute kidney injury following severe trauma: Risk factors and long-term outcome. J Trauma Acute Care Surg. 2015 Sep;79(3):407-12. doi: 10.1097/TA.0000000000000727.
- Background: PubMed 28842286Fujinaga J, Kuriyama A, Shimada N. Incidence and risk factors of acute kidney injury in the Japanese trauma population: A prospective cohort study. Injury. 2017 Oct;48(10):2145-2149. doi: 10.1016/j.injury.2017.08.022. Epub 2017 Aug 15.
- Background: PubMed 25885883Santos PR, Monteiro DL. Acute kidney injury in an intensive care unit of a general hospital with emergency room specializing in trauma: an observational prospective study. BMC Nephrol. 2015 Mar 19;16:30. doi: 10.1186/s12882-015-0026-4.
- Background: PubMed 23425757Talving P, Karamanos E, Skiada D, Lam L, Teixeira PG, Inaba K, Johnson J, Demetriades D. Relationship of creatine kinase elevation and acute kidney injury in pediatric trauma patients. J Trauma Acute Care Surg. 2013 Mar;74(3):912-6. doi: 10.1097/TA.0b013e318278954e.
- Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- Background: PubMed 25340231National Clinical Guideline Centre (UK). Acute Kidney Injury: Prevention, Detection and Management Up to the Point of Renal Replacement Therapy [Internet]. London: Royal College of Physicians (UK); 2013 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK247665/
- Background: PubMed 25615028Ricci Z, Romagnoli S. Prescription of dialysis in pediatric acute kidney injury. Minerva Pediatr. 2015 Apr;67(2):159-67. Epub 2015 Jan 23.
- Background: PubMed 28241247Kwiatkowski DM, Goldstein SL, Cooper DS, Nelson DP, Morales DL, Krawczeski CD. Peritoneal Dialysis vs Furosemide for Prevention of Fluid Overload in Infants After Cardiac Surgery: A Randomized Clinical Trial. JAMA Pediatr. 2017 Apr 1;171(4):357-364. doi: 10.1001/jamapediatrics.2016.4538.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut University.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Incidence of AKI in Pediatric Trauma Patients Admitted to ER (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06177886, which also lists 18 linked publications.
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 Dec 2023.