Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Minute - 2 Days
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06050525
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Karolinska Institutet
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Urban Fläring, MD. Ph.D.
Principal Investigator Affiliation	Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital. Stockholm. Sweden.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Congenital Diaphragmatic Hernia, Acute Kidney Injury, Multiple Organ Failure, Pulmonary Hypertension, Hyperchloremia

Additional Details

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.

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