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

NCT06050525 | Completed

• 1 other identifier: K 2023-7065
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Congenital Diaphragmatic Hernia; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of acute kidney injury in newborn patients with congenital diaphragmatic hernia (CDH) (n=108)

  Patients having or not having acute kidney injury will be determined by the score: neonatal Kidney Diseases: Improving Global Outcomes (n-KDIGO), based upon creatinine concentration (mikromoles/L). A 1.5-fold increase in creatinine concentration increase from first sampling will be classified as acute kidney injury.

  Acute kidney injury evolving during PICU-stay (from birth up to 10 weeks, which is the longest PICU-stay among the patients).)

Secondary Outcomes (5)

• Pulmonary hypertension

  Developing during PICU-stay (from birth up to 10 weeks)

• Use of nephrotoxic drugs

  Given during PICU-stay (from birth up to 10 weeks)

• Duration (days during first week in the PICU) of hyperchloremia

  From birth up to one week in the. PICU.

• Development of multiple organ failure.

  From birth up to one week in the PICU

• Mortality during PICU-stay (max 10 weeks).

  PICU-stay. (up to 10 weeks).

Eligibility Criteria

• Age: 1 Minute - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (4)

• 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.

  PMID: 29404689 BACKGROUND

• 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.

  PMID: 29732396 RESULT

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

  PMID: 31335403 RESULT

• 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.

  PMID: 34120147 RESULT

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Acute Kidney Injury; Multiple Organ Failure; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Shock; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Urban Fläring, MD. Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D. Associate Professor.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 22, 2023
• Study Start: February 1, 2023
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

SE (1)