Clinical trial NCT06050525: Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia
Official title: Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Diaphragmatic Hernia
Acute Kidney Injury
Multiple Organ Failure
Pulmonary Hypertension
Hyperchloremia
Keywords: Congenital Diaphragmatic Hernia
Acute Kidney Injury
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 109
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newborns with congenital diaphragmatic hernia, intubated and started invasive ventilation within 2 days, referred to Karolinska University Hospital, Stockholm, Sweden.

Brief summary: The main aim of this project is to elucidate the incidence of acute kidney injury (AKI) in newborns with congenital diaphragmatic hernia during stay in the Pediatric intensive care unit. (PICU). This patient group often presents with severe circulatory and respiratory dysfunction requiring intensive care treatment. Characterization of risk factors to AKI will also be performed.

Detailed description: There is an overwhelming number of studies showing that complication with acute kidney injury (AKI) in critically ill patients, including children and newborns results in increased morbidity and mortality. The more severe AKI, the higher risk of bad outcome. In the neonatal intensive care unit (NICU), the incidence of AKI is approximately 30 %, even higher in full-term babies (36 %).

Newborns with congenital diaphragmatic hernia (CDH) often present with severe cardio-respiratory dysfunction, often complicated by pulmonary hypertension (PPHN) requiring mechanical ventilation and vasoactive/inotropic drugs, especially during the first week in the intensive care. Some of these patients deteriorates and cannot maintain vital parameters despite conventional treatment and will therefore require extra corporeal membrane oxygenation). During the ICU-stay, the patients are subjected to several risk factors for developing AKI. Among physiological risk factors, PPHN, low oxygenation and blood pressure may result in renal dysfunction. Iatrogenic factors include the need for nephrotoxic drugs, not least antibiotics (Vancomycin, Gentamycin) and antimycotics. In addition, hyperchloremia may contribute to the development of AKI, since impaired renal blood flow is associated with hyperchloremia. The AKI incidence and its risk factors in CDH patients is not well studied.

The objectives of this well characterized retrospective cohort study is to establish AKI incidence in critically ill CDH-patients and investigate possible associations between risk factors and AKI (exposure to nephrotoxic drugs, degree of multiple organ failure, PPHN, vasoactive/inotropic requirement, oxygenation index, fluid overload and hyperchloremia) during PICU stay. The association of the risk factors to different stages of AKI will also be investigated.

Eligibility criteria: Inclusion Criteria: Newborns with congenital diaphragmatic hernia intubated and started invasive ventilation within 2 days.

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Exclusion Criteria:

* Invasive ventilation initiated after 2 days.
* Severe comorbidity not compatible with life and/or not possible to correct surgically.
* Death occurring within 2 days.

Primary outcomes:
measure: Incidence of acute kidney injury in newborn patients with congenital diaphragmatic hernia (CDH) (n=108)
timeFrame: Acute kidney injury evolving during PICU-stay (from birth up to 10 weeks, which is the longest PICU-stay among the patients).)
Secondary outcomes:
measure: Pulmonary hypertension
timeFrame: Developing during PICU-stay (from birth up to 10 weeks)
measure: Use of nephrotoxic drugs
timeFrame: Given during PICU-stay (from birth up to 10 weeks)
measure: Duration (days during first week in the PICU) of hyperchloremia
timeFrame: From birth up to one week in the. PICU.
measure: Development of multiple organ failure.
timeFrame: From birth up to one week in the PICU
measure: Mortality during PICU-stay (max 10 weeks).
timeFrame: PICU-stay. (up to 10 weeks).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital
Study officials:
affiliation: Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital. Stockholm. Sweden.
name: Urban Fläring, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barhight MF, Lusk J, Brinton J, Stidham T, Soranno DE, Faubel S, Goebel J, Mourani PM, Gist KM. Hyperchloremia is independently associated with mortality in critically ill children who ultimately require continuous renal replacement therapy. Pediatr Nephrol. 2018 Jun;33(6):1079-1085. doi: 10.1007/s00467-018-3898-2. Epub 2018 Feb 5.
citation: Jetton JG, Boohaker LJ, Sethi SK, Wazir S, Rohatgi S, Soranno DE, Chishti AS, Woroniecki R, Mammen C, Swanson JR, Sridhar S, Wong CS, Kupferman JC, Griffin RL, Askenazi DJ; Neonatal Kidney Collaborative (NKC). Incidence and outcomes of neonatal acute kidney injury (AWAKEN): a multicentre, multinational, observational cohort study. Lancet Child Adolesc Health. 2017 Nov;1(3):184-194. doi: 10.1016/S2352-4642(17)30069-X.
citation: Chatterjee D, Ing RJ, Gien J. Update on Congenital Diaphragmatic Hernia. Anesth Analg. 2020 Sep;131(3):808-821. doi: 10.1213/ANE.0000000000004324.
citation: Liberio BM, Brinton JT, Gist KM, Soranno DE, Kirkley MJ, Gien J. Risk factors for acute kidney injury in neonates with congenital diaphragmatic hernia. J Perinatol. 2021 Aug;41(8):1901-1909. doi: 10.1038/s41372-021-01119-1. Epub 2021 Jun 12.