Application of CLCVP Technique in Early Intervention of CSA-AKI

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about in postoperative acute kidney injury in cardiac surgery. The main questions it aims to answer are: Controlled low central venous pressure (CLCVP) technique can reduce the occurrence of cardiac surgery-associated acute kidney injury (CSA-AKI) by reducing venous congestion and increasing renal perfusion pressure. CLCVP technique does not increase the risk of postoperative cognitive dysfunction (POCD) during cardiac surgery. Participants who are assigned to the intervention group will receive CLCVP technique. Specific methods are as follows: First,20min after the end of cardiopulmonary bypass, on the basis of ensuring that the mean arterial pressure (MAP) ≥ 60mmHg, the patients will accept dorsal elevated position. After that, if the patient's central venous pressure (CVP) is less than 10mmHg, nitroglycerin will be pumped at 0.2ug/ (kg * min). If the patient's CVP is still greater than or equal 10mmHg, we increase the dose by 0.2ug/ (kg * min) and pump again for 5min, and the like. Until the patient's CVP is less than 10mmHg or the dose of nitroglycerin increases to 1ug/ (kg * min), the current dose is maintained until the end of surgery. If participants are assigned to the control group, no intervention measures will be taken. The researchers will compare the intervention group with the control group to see the occurrence of CSA-AKI and POCD after cardiac surgery.

Official Title
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Application of Controlled Low Central Venous Pressure Technique in Early Intervention of Cardiac Surgery-associated Acute Kidney Injury

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Combination Product: controlled low central venous pressure technique (CLCVP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years and older, who underwent cardiac surgery (coronary artery bypass grafting (CABG), heart valve surgery, heart transplant or surgical excision of intracardiac myxoma) were eligible for analyses. Exclusion Criteria: pre-existing renal insufficiency defined by presence of abnormal preoperative serum creatinine ≥ 133 μmol/L and/or preoperative diagnosis of renal insufficiency within 6 months' preoperative period. patients with preoperative dialysis dependence within 60 days before surgery, off-pump heart surgery, prior kidney transplantation, pregnancy, as well as those under drug therapy with nitroglycerin were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intervention group and control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>First,20min after the end of cardiopulmonary bypass, on the basis of ensuring that the mean arterial pressure (MAP) ≥ 60mmHg, the patients will accept dorsal elevated position. After that, if the patient's CVP is less than 10mmHg, nitroglycerin will be pumped at 0.2ug/ (kg * min). If the patient's CVP is still greater than or equal 10mmHg, we increase the dose by 0.2ug/ (kg * min) and pump again for 5min, and the like. Until the patient's CVP is less than 10mmHg or the dose of nitroglycerin increases to 1ug/ (kg * min), the current dose is maintained until the end of surgery. | Combination Product: controlled low central venous pressure technique (CLCVP)<br>* 20min after the end of cardiopulmonary bypass, on the basis of ensuring that the mean arterial pressure (MAP) ≥ 60mmHg, we maintain the patient's central venous pressure below 10 mmHg by adjusting the posture and pumping nitroglycerin.<br>|
| No Intervention: control group<br>no intervention measures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury (AKI) 1 | Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL) | preoperation, every day for 7 days after surgery | 
| Acute kidney injury (AKI) 2 | Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL) | one day after surgery | 
| Acute kidney injury (AKI) 3 | Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL) | three days after surgery | 
| Acute kidney injury (AKI) 4 | Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL) | 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative cognitive dysfunction (POCD) 1 | Diagnosis of postoperative POCD using MSE scales | preoperation | 
| Postoperative cognitive dysfunction (POCD) 2 | Diagnosis of postoperative POCD using MSE scales | 7 days after surgery | 
| Postoperative cognitive dysfunction (POCD) 3 | Diagnosis of postoperative POCD using MSE scales | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Kidney Injury (AKI), Controlled Low Central Venous Pressure (CLCVP), Central Venous Pressure (CVP), Postoperative Cognitive Dysfunction (POCD)