Congenital Diaphragmatic HerniaNCT06050525
Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia
An observational study of Congenital Diaphragmatic Hernia and Acute Kidney Injury, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 2 days
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Acute Kidney Injury, Multiple Organ Failure
- How many people
- 109 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to 25 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborns with congenital diaphragmatic hernia, intubated and started invasive ventilation within 2 days, referred to Karolinska University Hospital, Stockholm, Sweden.
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital
Stockholm, 17176
About this study
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.
Read the 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.
- Conditions
- Congenital Diaphragmatic Hernia, Acute Kidney Injury, Multiple Organ Failure, Pulmonary Hypertension, Hyperchloremia
- Keywords
- Congenital Diaphragmatic Hernia, Acute Kidney Injury
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Acute Kidney Injury, Multiple Organ Failure, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A patient is classified as having PPHN on the first echocardiogram if the right ventricular systolic blood pressure is 67% or more of the systemic blood pressure. Acute kidney injury will be determined using n-KDIGO described in Primary Outcome Measure. In the statistic analysis, the variables will be dichotomous. Possible association will be analysed using logistic regression analysis in this cohort of newborn patients with CDH (n=108)
Measured: Developing during PICU-stay (from birth up to 10 weeks)
Use of nephrotoxic drugs
If given 3 days or more during PICU-stay, Nephrotoxic drugs (Vancomycin, Meropenem, Gentamycin, Amphotericin B, Tazobactam and Fluconazole) will be investigated using logistic regression analysis to elucidate if there is an association with the development of acute kidney injury (defined by n-KDIGO) in this cohort of newborn patients with CDH (n=108)
Measured: Given during PICU-stay (from birth up to 10 weeks)
Duration (days during first week in the PICU) of hyperchloremia
Plasma chloride concentration has been obtained from blood gas analysis on a daily basis during the first week in the PICU. It will be investigated if days with a chloride concentration >110mmol/L is associated with the development of acute kidney injury (defined by n-KDIGO) using logistic regressionin this cohort of newborn patients with CDH (n=108)
Measured: From birth up to one week in the. PICU.
Development of multiple organ failure.
Maximum development of multiple organ failure during the first week in the PICU will be determined defined by the PEdiatric Logistic Organ Dysfunction Score (PELOD-2-score). Higher values means a worse. outcome. A possible association between PELOD-2 score and the development of acute kidney injury will be investigated using logistic regression in this cohort of newborn patients with CDH (n=108)
Measured: From birth up to one week in the PICU
Mortality during PICU-stay (max 10 weeks).
Association between the development of acute kidney injury defined by n-KDIGO and mortality occurring during PICU stay will be investigated using logistic regression in this cohort of newborn patients with CDH (n=108)
Measured: PICU-stay. (up to 10 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Feb 2023
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urban Fläring, Karolinska Institutet
- Investigators
- Urban Fläring, MD. Ph.D., Principal investigator, Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital. Stockholm. Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050525
- Sponsor's protocol ID
- K 2023-7065
- Status last verified
- Nov 2024
- First submitted
- 6 Sep 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29404689Jetton 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.
PubMed 29732396Chatterjee D, Ing RJ, Gien J. Update on Congenital Diaphragmatic Hernia. Anesth Analg. 2020 Sep;131(3):808-821. doi: 10.1213/ANE.0000000000004324.
PubMed 31335403Liberio 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.
PubMed 34120147
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT06050525
- Acronym / sponsor ID
- K 2023-7065
- Conditions
- Congenital Diaphragmatic Hernia, Acute Kidney Injury, Multiple Organ Failure, Pulmonary Hypertension, Hyperchloremia
- Keywords
- Congenital Diaphragmatic Hernia, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 minute to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns with congenital diaphragmatic hernia, intubated and started invasive ventilation within 2 days, referred to Karolinska University Hospital, Stockholm, Sweden.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Invasive ventilation initiated after 2 days.
- Severe comorbidity not compatible with life and/or not possible to correct surgically.
- Death occurring within 2 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of acute kidney injury in newborn patients with congenital diaphragmatic hernia (CDH) (n=108)
Time frame: Acute kidney injury evolving during PICU-stay (from birth up to 10 weeks, which is the longest PICU-stay among the patients).)
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.
5 secondary outcomes
Pulmonary hypertension
Time frame: Developing during PICU-stay (from birth up to 10 weeks)
Use of nephrotoxic drugs
Time frame: Given during PICU-stay (from birth up to 10 weeks)
Duration (days during first week in the PICU) of hyperchloremia
Time frame: From birth up to one week in the. PICU.
Development of multiple organ failure.
Time frame: From birth up to one week in the PICU
Mortality during PICU-stay (max 10 weeks).
Time frame: PICU-stay. (up to 10 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 29404689Barhight 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.
- Results publication: PubMed 29732396Jetton 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.
- Results publication: PubMed 31335403Chatterjee D, Ing RJ, Gien J. Update on Congenital Diaphragmatic Hernia. Anesth Analg. 2020 Sep;131(3):808-821. doi: 10.1213/ANE.0000000000004324.
- Results publication: PubMed 34120147Liberio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urban Fläring, MD. Ph.D. principal investigator
Department of Pediatric Anesthesia and Intensive Care. Karolinska University Hospital. Stockholm. Sweden.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Diaphragmatic Hernia and Acute Kidney Injury, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury in newborn patients with congenital diaphragmatic hernia (CDH) (n=108) (time frame: Acute kidney injury evolving during PICU-stay (from birth up to 10 weeks, which is the longest PICU-stay among the patients).)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06050525, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.