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Application of CLCVP Technique in Early Intervention of CSA-AKI

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05855954
Enrollment
200
Registered
2023-05-12
Start date
2023-05-01
Completion date
2025-12-30
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury (AKI), Controlled Low Central Venous Pressure (CLCVP), Central Venous Pressure (CVP), Postoperative Cognitive Dysfunction (POCD)

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

Acute kidney injury (AKI) is a common and serious complication after cardiac surgery, which is associated with worsen prognosis including longer hospitalization, elevated mortality and morbidity and greater healthcare costs.The pathophysiological mechanisms underlying the development of AKI after cardiac surgery are complex. Venous congestion during cardiac surgery rather than hypotension is independently associated with the postoperative adverse kidney events, for both AKI within 7 days postoperative and longer-term acute kidney disease (AKD) that develops between 8- and 90-day postoperative window.Central venous pressure (CVP) is used as an indicator to quantify the degree of venous congestion, and high CVP may reflect severe venous congestion, contributing to decreased organ perfusion pressure and negatively affect renal microcirculation. Controlled low central venous pressure (CLCVP) technique is a common and safe technique in clinical surgery.CLCVP technology has been widely used in hepatectomy, but there are few studies on its application in cardiac surgery settings. Most scholars believe that it has no adverse effects on the kidneys, while some studies suggest that it has a certain protective effect on the kidneys, but the mechanism is unclear.Actively targeting lower CVP levels using fluid restriction, reverse Trendelenburg position, vasodilators and other methods by anesthetics, can significantly reduce major intraoperative bleeding events.CLCVP technique could potentially play a role in renal protection during cardiac surgery by easing venous congestion through reduced CVP levels. We therefore carried out a controlled randomized clinical trial to study the effect of CLCVP technique on postoperative acute kidney complications after on-pump cardiac surgery. Specifically, we tested the hypothesis that CLCVP management reduces the incidence of postoperative AKI through lower intraoperative CVP levels.

Interventions

COMBINATION_PRODUCTcontrolled 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.

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

intervention group and control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Acute kidney injury (AKI) 1preoperation, Within 7 days after surgeryAcute Kidney Injury is defined as an absolute increase in serum creatinine of ≥0. 3 mg/dL (≥26. 5 mmol/L) within 2 days or a 1. 5-fold increase in serum creatinine from baseline within 7 days, or UO \<0. 5 ml/kg/h for more than 6 hours in the ICU after surgery
Acute kidney injury (AKI) 2one day after surgeryAcute Kidney Injury is defined as an absolute increase in serum creatinine of ≥0. 3 mg/dL (≥26. 5 mmol/L) within 2 days or a 1. 5-fold increase in serum creatinine from baseline within 7 days, or UO \<0. 5 ml/kg/h for more than 6 hours in the ICU after surgery
Acute kidney injury (AKI) 3three days after surgeryAcute Kidney Injury is defined as an absolute increase in serum creatinine of ≥0. 3 mg/dL (≥26. 5 mmol/L) within 2 days or a 1. 5-fold increase in serum creatinine from baseline within 7 days, or UO \<0. 5 ml/kg/h for more than 6 hours in the ICU after surgery
Acute kidney injury (AKI) 47 days after surgeryAcute Kidney Injury is defined as an absolute increase in serum creatinine of ≥0. 3 mg/dL (≥26. 5 mmol/L) within 2 days or a 1. 5-fold increase in serum creatinine from baseline within 7 days, or UO \<0. 5 ml/kg/h for more than 6 hours in the ICU after surgery

Secondary

MeasureTime frameDescription
Postoperative cognitive dysfunction (POCD) 27 days after surgeryDiagnosis of postoperative POCD using MSE scales
Postoperative cognitive dysfunction (POCD) 330 days after surgeryDiagnosis of postoperative POCD using MSE scales
Postoperative cognitive dysfunction (POCD) 1preoperationDiagnosis of postoperative POCD using MSE scales

Countries

China

Contacts

Primary ContactYali Ge, Doctor
ge_yl@163.comChina+025-52271064
Backup ContactLanxin Hu, BS
hlx20877520@163.comChina + 025-52271064

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026