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

NCT ID: NCT06050525

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-11-25

Brief Summary

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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

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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.

Conditions

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Congenital Diaphragmatic Hernia Acute Kidney Injury Multiple Organ Failure Pulmonary Hypertension Hyperchloremia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\-

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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Urban Fläring

M.D. Ph.D. Associate Professor.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Urban Fläring, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital. Stockholm. Sweden.

Locations

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Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 29404689 (View on PubMed)

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.

Reference Type RESULT
PMID: 29732396 (View on PubMed)

Chatterjee D, Ing RJ, Gien J. Update on Congenital Diaphragmatic Hernia. Anesth Analg. 2020 Sep;131(3):808-821. doi: 10.1213/ANE.0000000000004324.

Reference Type RESULT
PMID: 31335403 (View on PubMed)

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.

Reference Type RESULT
PMID: 34120147 (View on PubMed)

Other Identifiers

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K 2023-7065

Identifier Type: -

Identifier Source: org_study_id