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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | 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. |
|
| control group | No Intervention | no intervention measures |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury (AKI) 1 | 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 | preoperation, Within 7 days after surgery |
| Acute kidney injury (AKI) 2 | 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 | one day after surgery |
| Acute kidney injury (AKI) 3 | 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 | three days after surgery |
| Acute kidney injury (AKI) 4 | 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 | 7 days after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yali Ge, Doctor | Contact | China+025-52271064 | ge_yl@163.com | |
| Lanxin Hu, BS | Contact | China + 025-52271064 | 13476712087 | hlx20877520@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yali Ge, Doctor | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35249707 | Background | 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. 2022 May;128(5):785-795. doi: 10.1016/j.bja.2022.01.032. Epub 2022 Mar 4. | |
| 33549321 |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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intervention group and control group
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|
| 7 days after surgery |
| Postoperative cognitive dysfunction (POCD) 3 | Diagnosis of postoperative POCD using MSE scales | 30 days after surgery |
| 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;126(3):599-607. doi: 10.1016/j.bja.2020.12.028. Epub 2021 Feb 4. |
| 25387727 | Background | 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: assessment of 2116 cases. HPB (Oxford). 2015 Mar;17(3):258-64. doi: 10.1111/hpb.12347. Epub 2014 Nov 11. |
| 34343737 | Background | 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 1. |
| 41466406 | Derived | Cheng Y, Li L, Zhang J, Zhou J, Chen L, Shi H, Wang Y, He W, Yang F. Prediction of intraoperative acquired pressure injury in elderly cardiac surgery patients via machine learning: model development with the MIMIC-IV and external validation. BMC Med Inform Decis Mak. 2025 Dec 29;26(1):33. doi: 10.1186/s12911-025-03325-9. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |