Acute Kidney Injury in Pediatric Polytrauma Patients at Assiut University Trauma Unit: A Cross-Sectional Study on Incidence and Predictive Risk Factors

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06177886
• Other study ID #: AKIPPP
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 aims at preventing AKI

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Multiple Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (18)

Bagshaw 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. — View Citation

Bojan 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. — View Citation

de Abreu KL, Silva Junior GB, Barreto AG, Melo FM, Oliveira BB, Mota RM, Rocha NA, Silva SL, Araujo SM, Daher EF. Acute kidney injury after trauma: Prevalence, clinical characteristics and RIFLE classification. Indian J Crit Care Med. 2010 Jul;14(3):121-8. doi: 10.4103/0972-5229.74170. — View Citation

Eriksson 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. — View Citation

Fujinaga 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. — View Citation

Harrois 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. — View Citation

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. — View Citation

Kellum JA, Bellomo R, Ronco C. Classification of acute kidney injury using RIFLE: What's the purpose? Crit Care Med. 2007 Aug;35(8):1983-4. doi: 10.1097/01.CCM.0000277518.67114.F8. No abstract available. — View Citation

Kwiatkowski 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. — View Citation

Kwiatkowski 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. — View Citation

Li J, Han B, Li H, Deng H, Mendez-Sanchez N, Guo X, Qi X. Association of coagulopathy with the risk of bleeding after invasive procedures in liver cirrhosis. Saudi J Gastroenterol. 2018 Jul-Aug;24(4):220-227. doi: 10.4103/sjg.SJG_486_17. — View Citation

National 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/ — View Citation

National 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. — View Citation

Reilly 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. — View Citation

Ricci Z, Romagnoli S. Prescription of dialysis in pediatric acute kidney injury. Minerva Pediatr. 2015 Apr;67(2):159-67. Epub 2015 Jan 23. — View Citation

Santos 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. — View Citation

Talving 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. — View Citation

Webb TN, Goldstein SL. Congenital heart surgery and acute kidney injury. Curr Opin Anaesthesiol. 2017 Feb;30(1):105-112. doi: 10.1097/ACO.0000000000000406. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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	baseline
Primary	timing of AKI in pediatric trauma patients admitted to ER	time period between admission and diagnosis of AKI	baseline
Secondary	Risk Identification of AKI in pediatric trauma patients	Identifying risk for AKI as presence of shock and/or rhabdomyolysis. Exposure to nephrotoxic drugs .	baseline
Secondary	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.	Baseline