Application of CLCVP Technique in Early Intervention of CSA-AKI

NCT05855954 | Recruiting DMC

• 1 other identifier: ClinicalTrials20230321
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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. 2.CLCVP technique does not increase the risk of postoperative cognitive dysfunction (POCD) during cardiac surgery.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Postoperative cognitive dysfunction (POCD) 1

  preoperation

• Postoperative cognitive dysfunction (POCD) 2

  7 days after surgery

• Postoperative cognitive dysfunction (POCD) 3

  30 days after surgery

Study Arms (2)

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.

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

control group

NO INTERVENTION

no intervention measures

Interventions

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210012, China

RECRUITING

Related 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. 2022 May;128(5):785-795. doi: 10.1016/j.bja.2022.01.032. Epub 2022 Mar 4.

  PMID: 35249707 BACKGROUND

• 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.

  PMID: 33549321 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.

  PMID: 25387727 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.

  PMID: 34343737 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yali Ge, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Yali Ge, Doctor

CONTACT

China+025-52271064; ge_yl@163.com

Lanxin Hu, BS

CONTACT

China + 025-52271064; hlx20877520@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: intervention group and control group

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: May 12, 2023
• Study Start: May 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)