Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622291
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type a Aortic Dissection Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Nitric Oxide Administration for Reducing the Risk of Acute Kidney Injury in Patients with Acute Type a Aortic Dissection a Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the effectiveness of exogenous nitric oxide therapy in reducing the occurrence of acute kidney injury in patients with acute type A aortic dissection Additionally it aims to assess the safety of exogenous nitric oxide therapy
Detailed Description:
The incidence of acute kidney injury following acute type A aortic dissection is significantly high thereby exerting a substantial impact on patient prognosis Nitric oxide an endogenous gaseous molecule with potential therapeutic effects has been investigated in clinical studies as a treatment for acute kidney injury following cardiac surgery However there is currently no clinical study exploring the application of nitric oxide in patients with acute type A aortic dissection Therefore this study aims to investigate whether exogenous nitric oxide therapy has renal protective effects and its mechanism
This prospective randomized study is conducted at Beijing Anzhen Hospital in Beijing China A total of 216 adult patients with acute type A aortic dissection are enrolled in this study The patients are randomly divided into two groups the experimental group received NO combined with conventional treatment and the control group is only given conventional treatment In the experimental group 60 ppm NO is administered during intraoperative CPB and continued until within 12 hours after surgery
The primary endpoint is the incidence of acute kidney injury AKI The secondary endpoints include AKI grade KDIGO urine volume during surgery within 12 and 24 hours after surgery blood flow grade resistance index and pulsatility index in renal ultrasound at ICU admission 12 and 24 hours after surgery SOFA score at 24 hours after surgery VIS score at ICU admission 12 and 24 hours after surgery duration of mechanical ventilation non-invasive ventilation and high-flow oxygen therapy length of ICU stay and hospital stay renal adverse events within 90 days volume of drainage from the pleural and pericardial cavities after surgery Additionally dosage of diuretics and recombinant human brain natriuretic peptide during surgery and within 7 days after surgery oxygenation index and near-renal infrared oxygen saturation levels of free hemoglobin methemoglobin nitrite NO2- and the total of NO metabolites NOt urine neutrophil gelatinase-associated lipocalin concentration reaction time R time kinetic time K time alpha angle α maximum amplitude MA and percentage cleavage at 30 minutes Ly30 plasma activated partial prothrombin time APTT prothrombin time PT fibrinogen degradation products FDP fibrinogen FBG D-dimer platelet count PLT mean platelet volume MPV platelet distribution width PDW and plateletcrit PCV levels of Interleukin-6 IL-6 procalcitonin PCT the neutrophils lymphocytes ratio NLR the platelet lymphocyte ratio PLR systemic inflammatory response index SIRI and systemic immune response index SII Pv-aCO2Ca-vO2 ratio values of Pv-aCO2 CVP and PEEP volume of transfusions with plasma and stored or autologous RBCs will also be measured in both groups
This prospective randomized study is conducted at Beijing Anzhen Hospital in Beijing China A total of 216 adult patients with acute type A aortic dissection are enrolled in this study The patients are randomly divided into two groups the experimental group received NO combined with conventional treatment and the control group is only given conventional treatment In the experimental group 60 ppm NO is administered during intraoperative CPB and continued until within 12 hours after surgery
The primary endpoint is the incidence of acute kidney injury AKI The secondary endpoints include AKI grade KDIGO urine volume during surgery within 12 and 24 hours after surgery blood flow grade resistance index and pulsatility index in renal ultrasound at ICU admission 12 and 24 hours after surgery SOFA score at 24 hours after surgery VIS score at ICU admission 12 and 24 hours after surgery duration of mechanical ventilation non-invasive ventilation and high-flow oxygen therapy length of ICU stay and hospital stay renal adverse events within 90 days volume of drainage from the pleural and pericardial cavities after surgery Additionally dosage of diuretics and recombinant human brain natriuretic peptide during surgery and within 7 days after surgery oxygenation index and near-renal infrared oxygen saturation levels of free hemoglobin methemoglobin nitrite NO2- and the total of NO metabolites NOt urine neutrophil gelatinase-associated lipocalin concentration reaction time R time kinetic time K time alpha angle α maximum amplitude MA and percentage cleavage at 30 minutes Ly30 plasma activated partial prothrombin time APTT prothrombin time PT fibrinogen degradation products FDP fibrinogen FBG D-dimer platelet count PLT mean platelet volume MPV platelet distribution width PDW and plateletcrit PCV levels of Interleukin-6 IL-6 procalcitonin PCT the neutrophils lymphocytes ratio NLR the platelet lymphocyte ratio PLR systemic inflammatory response index SIRI and systemic immune response index SII Pv-aCO2Ca-vO2 ratio values of Pv-aCO2 CVP and PEEP volume of transfusions with plasma and stored or autologous RBCs will also be measured in both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None