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NCT Number: NCT05855954

Application of CLCVP Technique in Early Intervention of CSA-AKI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210012, China

Location status: Recruiting

Location contact

Yali Ge, Doctor

CONTACT

[email protected]

China + 025-52271064

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

controlled low central venous pressure technique (CLCVP)

Combination Product

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.

Primary outcomes

  1. Acute kidney injury (AKI) 1

    Time frame: preoperation, Within 7 days after surgery

    Acute 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

  2. Acute kidney injury (AKI) 2

    Time frame: one day after surgery

    Acute 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

  3. Acute kidney injury (AKI) 3

    Time frame: three days after surgery

    Acute 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

  4. Acute kidney injury (AKI) 4

    Time frame: 7 days after surgery

    Acute 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 outcomes

  1. Postoperative cognitive dysfunction (POCD) 1

    Time frame: preoperation

    Diagnosis of postoperative POCD using MSE scales

  2. Postoperative cognitive dysfunction (POCD) 2

    Time frame: 7 days after surgery

    Diagnosis of postoperative POCD using MSE scales

  3. Postoperative cognitive dysfunction (POCD) 3

    Time frame: 30 days after surgery

    Diagnosis of postoperative POCD using MSE scales

Study contacts

Contact information is provided by the study sponsor or research team.

Lanxin Hu, BS

CONTACT

[email protected]

China + 025-52271064 ext. 13476712087

Yali Ge, Doctor

CONTACT

[email protected]

China+025-52271064

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 12, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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