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Acute Kidney InjuryPhase 2/3NCT04259684

Nitric Oxide During Cardiopulmonary Bypass in Neonates to Reduce Risk of Acute Kidney Injury

A Phase 2/3 study testing gases Nitric Oxide (gNO) in people with Acute Kidney Injury and Congenital Heart Disease, run by Children's Hospital Medical Center, Cincinnati.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Acute kidney injury following cardiac surgery for congenital heart defects in children is a major cause of both short- and long-term morbidity and mortality, affecting up to 60% of high risk patients. Read more about this study

Who is it for?
Ages Up to 31 days
Conditions the study is for
Acute Kidney Injury, Congenital Heart Disease
What is being tested?
gases Nitric Oxide (gNO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
20 Oct 2019to 20 Oct 2019
Phase
Phase 2/3
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 Up to 31 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Neonates (≤31 days) undergoing cardiac surgery with cardiopulmonary bypass for congenital heart disease

Who cannot join

  • 1. Failure to obtain informed consent from parent/guardian,
  • Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
  • Emergency surgery,
  • Episode of cardiac arrest within 1 week before surgery,
  • Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
  • Use of inhaled NO (iNO) immediately prior to surgery,
Show all 12Show fewer
  • Structural renal abnormalities by ultrasound,
  • Preoperative AKI,
  • Use of other investigational drugs,
  • Weight less than <2.2 kg,
  • Gestational age <36 weeks,
  • Major extracardiac congenital anomalies.

About this study

Official title: Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury: a Preliminary Double-blind Randomized Controlled Trial

Acute kidney injury following cardiac surgery for congenital heart defects in children is a major cause of both short- and long-term morbidity and mortality, affecting up to 60% of high risk patients. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Based on preliminary data available in the literature, we hypothesize that nitric oxide (gNO), administered during cardiopulmonary bypass (CPB), may reduce the risk of acute kidney injury (AKI) via mechanisms of reduced inflammation and vasodilation. In this pilot study, 40 neonates undergoing cardiac surgery will be randomized to receive intraoperative administration of 20 ppm of nitric oxide to the oxygenator of the cardiopulmonary bypass circuit or standard CPB with no additional gas.

Being tested
gases Nitric Oxide (gNO)
Medical subject headings
Acute Kidney Injury, Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gases Nitric Oxide (gNO)Drug

    Participants in the intervention group will receive gNO blended into the fresh gas flow of the cardiopulmonary bypass (CPB) oxygenator and maintained at 20 ppm via an Ikaria INO Max DSIR (Mallinckrodt Pharmaceuticals, St. Louis, Missouri, USA), with continuous sampling of NO and NO2 concentration from a port adjacent to the oxygenator. The gNO delivery will be initiated when the patient is on CPB and stopped once the patient comes off CPB.

Study groups in NCT04259684
Study groupRoleWhat they receive
gNO GroupExperimentalParticipants in the treatment group will receive gNO added to the oxygenator gas flow at 20 ppm throughout the duration of cardiopulmonary bypass.
Receives: Drug: gases Nitric Oxide (gNO)
Control GroupNo interventionParticipants in the control group will receive standard conduction of cardiopulmonary bypass.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Kidney Injury

    Occurrence of acute kidney defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (employing both serum creatinine and urine output criteria).

    Measured: up to 72 hours postoperative

  2. Glomerular Filtration Rate

    Postoperative glomerular filtration rate (GFR) measured using serum cystatin C.

    Measured: up to 72 hours postoperative

Secondary outcomes (13)

  1. Structural Kidney Injury

    Assessed by measurement of urine biomarkers: neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), interleukin-18 (IL-18) liver-type fatty acid-binding protein (L-FABP), and urinary nitrate.

    Measured: up to 72 hours postoperative

  2. Low cardiac output syndrome (LCOS)

    Occurence of low cardiac output syndrome (LCOS) defined as any of the following at any time during the first 48 hours postoperative:

    1. Lactate >6mmol/l and central venous saturation (ScvO2) <60% (or SaO2-ScvO2 difference greater than 35% in a single ventricle),
    2. Vasoactive inotropic score (VIS)24 ≥ 10,
    3. Extracorporeal Membrane Oxygenation (ECMO).

    Measured: up to 48 hours postoperative

  3. Duration of mechanical ventilation

    hours/days

    Measured: up to 2 weeks from admission to CICU to extubation

  4. Length of cardiac intensive care unit (CICU) stay

    days

    Measured: up to 2 weeksfrom admission to CICU to discharge from CICU

  5. Length of hospital stay

    days

    Measured: up to 30 days from hospital admission to discharge

  6. Inotrope free days

    days

    Measured: up to 30 days after surgery to CICU discharge

  7. ECMO free days

    Extracorporeal Membrane Oxygenation free days

    Measured: up to 2 weeks after surgery to CICU discharge

  8. Closed sternum days

    days

    Measured: up to 2 weeks from postoperative CICU admission to discharge

  9. Time to negative fluid balance

    hours/days

    Measured: up to 2 weeks from CICU admission to outcome reached

  10. Urine Output

    ml

    Measured: up to two weeks from CICU admission to discharge

  11. Use of peritoneal dialysis

    yes/no

    Measured: up to two weeks from CICU admission to discharge

  12. Cardiac arrest

    yes/no

    Measured: up to two weeks from CICU admission to discharge

  13. Use of postoperative inhaled Nitric Oxide (iNO)

    yes/no, indication, dose

    Measured: up to two weeks from CICU admission to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start20 Oct 2019
  3. Primary completion20 Oct 2019
  4. Study completion20 Oct 2019

Why it stopped: revised and combined with another protocol

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Each of the 40 participants will be stratified based on type of lesion (single ventricle vs. biventricular lesions) and block randomized into 1 of 2 study arms: treatment arm (receiving intraoperative administration of 20 ppm of gNO to the oxygenator of the CPB circuit) and control arm (standard CPB conduct).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04259684
Sponsor's protocol ID
CIN001-gNO to prevent AKI
Status last verified
Oct 2019
First submitted
19 Mar 2019
Last updated
6 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing gases Nitric Oxide (gNO) in people with Acute Kidney Injury and Congenital Heart Disease, run by Children's Hospital Medical Center, Cincinnati.

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 1 inclusion and 12 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: withdrawn, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Acute Kidney Injury (time frame: up to 72 hours postoperative). The study lists 2 primary outcomes in all. 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 NCT04259684.

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 6 Feb 2020.

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