Acute Kidney InjuryNCT03658148
Hematologic Ratios in Postoperative Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Acute kidney injury (AKI) is a common complication after surgery for congenital heart disease and is associated with significant morbidity and mortality. To-date, no biomarker has been universally implemented for predicting AKI in neonates after cardiac surgery. Read more about this study
- Who is it for?
- Ages 0 to 31 days
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Cardiac Surgery with Cardiopulmonary Bypass
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Jun 2021
- 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 0 to 31 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease between 2008-2017.
Who may be able to join
- Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease.
Who cannot join
- Patients with missing relevant preoperative or postoperative data points
- Patients with previous palliation or reoperation,
- Thymus hypo/aplasia (DiGeorge Syndrome, Ataxia-telangiectasia, or Nezelof syndrome),
- Primary immunodeficiency,
- Episode of cardiac arrest within 1 week before surgery,
- Signs or history of preoperative renal impairment or AKI (KDIGO Stage ≥1 observed on preoperative labs),
- Hypothyroidism,
- Patients with a history of infection within a week prior to surgery or antibiotics administered within the first 3 days after surgery (except for postoperative antibiotics).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45220
About this study
Official title: Association Between Hematological Ratios and Acute Kidney Injury After Cardiovascular Surgery in Neonates: a Retrospective Observational Study
Acute kidney injury (AKI) is a common complication after surgery for congenital heart disease and is associated with significant morbidity and mortality. To-date, no biomarker has been universally implemented for predicting AKI in neonates after cardiac surgery. In this study, the use of hematological ratios will be evaluated for predicting AKI and postoperative outcomes in this patient cohort.
Read the detailed description
In adults, hematological ratios which can be calculated from a routinely ordered complete blood count with differential, such as the neutrophil/lymphocyte ratio, have been demonstrated to be correlated with acute kidney injury (AKI) and other clinical outcomes after cardiovascular surgery. In this retrospective observational study, the association between hematological ratios (neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, neutrophil/lymphocyte*platelet ratio, monocyte/lymphocyte ratio, and plateletcrit) and postoperative AKI, morbidity (length of ICU stay, hospital stay, mechanical ventilation, vasoactive infusion-free days, etc.) and mortality will be evaluated in neonates who underwent cardiac surgery with cardiopulmonary bypass.
- Conditions
- Acute Kidney Injury
- Being tested
- Cardiac Surgery with Cardiopulmonary Bypass
- Keywords
- Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass, Congenital Heart Disease, Biomarkers
- 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.
Cardiac Surgery with Cardiopulmonary BypassProcedure or surgery
Cardiac Surgery with Cardiopulmonary Bypass
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease (CHD) between 2008-2017. Receives: Procedure: Cardiac Surgery with Cardiopulmonary Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury (AKI)
Occurrence of AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (using serum creatinine)
Measured: up to 72 hours postoperative
Secondary outcomes (8)
Operative Mortality
Mortality within 30 days after surgery (rate)
Measured: up to 30 days postoperative
1-year mortality
Mortality within 1 year after surgery (rate)
Measured: up to 1 year postoperative
Length of hospital stay
Total length of hospital stay (days)
Measured: up to 1 year postoperative
Length of Cardiac Intensive Care Unit (CICU) Stay
Total length of stay in the CICU (days)
Measured: up to 1 year postoperative
Length of mechanical ventilation
Total length of postoperative mechanical ventilator support (days)
Measured: up to 1 year postoperative
Vasoactive infusion-free days
(days)
Measured: up to 28 days postoperative
Postoperative infection
Occurrence of infection defined as: antibiotic use (other than perioperative) within 3 days postop, positive blood culture within 3 days postop, positive viral panel within 3 days postop
Measured: up to 3 days postoperative
Low Cardiac Output Syndrome
Occurrence of Low Cardiac Output Syndrome defined as any of the following at any time during the first 48 hours postoperative:
- Lactate >6mmol/l and mixed venous saturation (ScvO2) <60% (or SaO2-ScvO2 difference greater than 35% in a single ventricle),
- Vasoactive inotropic score (VIS)3 ≥ 10,
- Extracorporeal Membrane Oxygenation (ECMO
Measured: up to 2 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Jul 2018
- Primary completion1 Nov 2020
- Study completion1 Jun 2021
Why it stopped: No charts were reviewed. This study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658148
- Sponsor's protocol ID
- CIN001-AKI Hematologic Ratios
- Status last verified
- Jun 2021
- First submitted
- 6 Aug 2018
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Hematological Ratios and Acute Kidney Injury After Cardiovascular Surgery in Neonates: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT03658148
- Acronym / sponsor ID
- CIN001-AKI Hematologic Ratios
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass, Congenital Heart Disease, Biomarkers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No charts were reviewed. This study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Sep 2018 (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.
Acute kidney injury (AKI) is a common complication after surgery for congenital heart disease and is associated with significant morbidity and mortality. To-date, no biomarker has been universally implemented for predicting AKI in neonates after cardiac surgery. In this study, the use of hematological ratios will be evaluated for predicting AKI and postoperative outcomes in this patient cohort.
Detailed description
In adults, hematological ratios which can be calculated from a routinely ordered complete blood count with differential, such as the neutrophil/lymphocyte ratio, have been demonstrated to be correlated with acute kidney injury (AKI) and other clinical outcomes after cardiovascular surgery. In this retrospective observational study, the association between hematological ratios (neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, neutrophil/lymphocyte*platelet ratio, monocyte/lymphocyte ratio, and plateletcrit) and postoperative AKI, morbidity (length of ICU stay, hospital stay, mechanical ventilation, vasoactive infusion-free days, etc.) and mortality will be evaluated in neonates who underwent cardiac surgery with cardiopulmonary bypass.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: Cardiac Surgery with Cardiopulmonary BypassNeonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease (CHD) between 2008-2017. |
Who may qualify
- Ages
- 0 to 31 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease between 2008-2017.
Key inclusion criteria (1 listed)
- Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease.
Key exclusion criteria (8 listed)
- Patients with missing relevant preoperative or postoperative data points
- Patients with previous palliation or reoperation,
- Thymus hypo/aplasia (DiGeorge Syndrome, Ataxia-telangiectasia, or Nezelof syndrome),
- Primary immunodeficiency,
- Episode of cardiac arrest within 1 week before surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Surgery with Cardiopulmonary BypassCardiac Surgery with Cardiopulmonary Bypass | Procedure or surgery | Study Group |
Primary outcome
Acute Kidney Injury (AKI)
Time frame: up to 72 hours postoperative
Occurrence of AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (using serum creatinine)
8 secondary outcomes
Operative Mortality
Time frame: up to 30 days postoperative
1-year mortality
Time frame: up to 1 year postoperative
Length of hospital stay
Time frame: up to 1 year postoperative
Length of Cardiac Intensive Care Unit (CICU) Stay
Time frame: up to 1 year postoperative
Length of mechanical ventilation
Time frame: up to 1 year postoperative
Vasoactive infusion-free days
Time frame: up to 28 days postoperative
Postoperative infection
Time frame: up to 3 days postoperative
Low Cardiac Output Syndrome
Time frame: up to 2 days postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Kidney Injury, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 8 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 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 United States. 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 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 (AKI) (time frame: up to 72 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2024.