Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03658148
Other study ID # CIN001-AKI Hematologic Ratios
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date June 1, 2021

Study information

Verified date June 2021
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. In this study, the use of hematological ratios will be evaluated for predicting AKI and postoperative outcomes in this patient cohort.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 1, 2021
Est. primary completion date November 1, 2020
Accepts healthy volunteers
Gender All
Age group N/A to 31 Days
Eligibility Inclusion Criteria: - Neonates (=31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease. Exclusion Criteria: - 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).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiac Surgery with Cardiopulmonary Bypass
Cardiac Surgery with Cardiopulmonary Bypass

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute Kidney Injury (AKI) Occurrence of AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (using serum creatinine) up to 72 hours postoperative
Secondary Operative Mortality Mortality within 30 days after surgery (rate) up to 30 days postoperative
Secondary 1-year mortality Mortality within 1 year after surgery (rate) up to 1 year postoperative
Secondary Length of hospital stay Total length of hospital stay (days) up to 1 year postoperative
Secondary Length of Cardiac Intensive Care Unit (CICU) Stay Total length of stay in the CICU (days) up to 1 year postoperative
Secondary Length of mechanical ventilation Total length of postoperative mechanical ventilator support (days) up to 1 year postoperative
Secondary Vasoactive infusion-free days (days) up to 28 days postoperative
Secondary 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 up to 3 days postoperative
Secondary 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
up to 2 days postoperative
See also
  Status Clinical Trial Phase
Recruiting NCT05538351 - A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03938038 - Guidance of Ultrasound in Intensive Care to Direct Euvolemia N/A
Recruiting NCT05805709 - A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial N/A
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Recruiting NCT05897840 - Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients N/A
Recruiting NCT04986137 - Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Terminated NCT04293744 - Acute Kidney Injury After Cardiac Surgery N/A
Completed NCT04095143 - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Not yet recruiting NCT06026592 - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Not yet recruiting NCT06064305 - Transcriptional and Proteomic Analysis of Acute Kidney Injury
Terminated NCT03438877 - Intensive Versus Regular Dosage For PD In AKI. N/A
Terminated NCT03305549 - Recovery After Dialysis-Requiring Acute Kidney Injury N/A
Completed NCT05990660 - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery N/A
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Terminated NCT02860130 - Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT) Phase 3
Completed NCT06000098 - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Not yet recruiting NCT05548725 - Relation Between Acute Kidney Injury and Mineral Bone Disease
Completed NCT02665377 - Prevention of Akute Kidney Injury, Hearttransplant, ANP Phase 3
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A