Application of CLCVP Technique in Early Intervention of CSA-AKI

Not Applicable

Not yet recruiting

• Conditions: Acute Kidney Injury
• Interventions: Combination Product: controlled low central venous pressure technique (CLCVP)

• Registration Number: NCT05855954
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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:

1. 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.

2. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-21
• Status Verified: 2023-04
• Study Start: 2023-05-01
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	controlled low central venous pressure technique (CLCVP)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative cognitive dysfunction (POCD) 1	preoperation	Diagnosis of postoperative POCD using MSE scales
Postoperative cognitive dysfunction (POCD) 2	7 days after surgery	Diagnosis of postoperative POCD using MSE scales
Postoperative cognitive dysfunction (POCD) 3	30 days after surgery	Diagnosis of postoperative POCD using MSE scales

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China