Application of CLCVP Technique in Early Intervention of CSA-AKI

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05855954
• Other study ID #: ClinicalTrials20230321
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Combination Product:
• controlled low central venous pressure technique (CLCVP)
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.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Chen L, Hong L, Ma A, Chen Y, Xiao Y, Jiang F, Huang R, Zhang C, Bu X, Ge Y, Zhou J. Intraoperative venous congestion rather than hypotension is associated with acute adverse kidney events after cardiac surgery: a retrospective cohort study. Br J Anaesth. — View Citation

Correa-Gallego C, Berman A, Denis SC, Langdon-Embry L, O'Connor D, Arslan-Carlon V, Kingham TP, D'Angelica MI, Allen PJ, Fong Y, DeMatteo RP, Jarnagin WR, Melendez J, Fischer M. Renal function after low central venous pressure-assisted liver resection: as — View Citation

Liu TS, Shen QH, Zhou XY, Shen X, Lai L, Hou XM, Liu K. Application of controlled low central venous pressure during hepatectomy: A systematic review and meta-analysis. J Clin Anesth. 2021 Dec;75:110467. doi: 10.1016/j.jclinane.2021.110467. Epub 2021 Aug — View Citation

Lopez MG, Shotwell MS, Morse J, Liang Y, Wanderer JP, Absi TS, Balsara KR, Levack MM, Shah AS, Hernandez A, Billings FT 4th. Intraoperative venous congestion and acute kidney injury in cardiac surgery: an observational cohort study. Br J Anaesth. 2021 Mar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Postoperative cognitive dysfunction (POCD) 1	Diagnosis of postoperative POCD using MSE scales	preoperation
Secondary	Postoperative cognitive dysfunction (POCD) 2	Diagnosis of postoperative POCD using MSE scales	7 days after surgery
Secondary	Postoperative cognitive dysfunction (POCD) 3	Diagnosis of postoperative POCD using MSE scales	30 days after surgery