Nitric Oxide During CPB to Reduce AKI in Neonates

Status Withdrawn

Clinical Trial Summary

This is a prospective, randomized, double-blind, placebo-controlled pilot study to investigate whether supplemental Nitric Oxide (NO) gas delivered during cardiac surgery with cardiopulmonary bypass (CPB) reduces the incidence and impact of acute kidney injury (AKI) in neonates undergoing surgery for congenital heart disease (CHD), when compared to placebo gas

Clinical Trial Description

Screening: All patients undergoing either elective or emergency cardiac surgery will be screened against the eligibility criteria. Research Sample Collection: Blood and urine will be collected for the first 48 hours admission and analyzed. The specific time points for these parameters will be: 2 hours, 6 hours, 12 hours 24 hours, and 48 hours post admission. Blood and urine parameters will also be collected as a baseline pre-operative. Patient outcomes will be captured for 30 days post operatively. Research Data Collection: Baseline information will be collected. Other research related variables collected during the surgical intervention and bypass. Additional information will be collected 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after admission as well as outcomes 30 days after the procedure. Participants will be randomly allocated to the NO or control group in a 1:1 ratio. This study is investigating a possible protective role for NO gas administration during bypass on the subsequent development of AKI. NO is typically delivered via large, stand-alone cylinders that are placed at the bedside (or adjacent to the patient) and is set up by respiratory therapists. In this research study, the study gas (NO or placebo) will be delivered directly into the bypass circuit at a constant gas flow. The placebo gas in this study will be 21% (or atmospheric) oxygen, and will appear to all members of the clinical and research teams (with the exception of the respiratory therapist responsible for setting it up) indistinguishable from NO, rendering this a double-blind study for the patient (or caregiver) and the investigators. This minimizes any possibility of bias in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03946462
Study type	Interventional
Source	Baylor College of Medicine
Contact
Status	Withdrawn
Phase	Phase 1
Start date	October 2021
Completion date	March 2023

View Details

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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.