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Application of CLCVP Technique in Early Intervention of CSA-AKI

Primary Purpose

Acute Kidney Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
controlled low central venous pressure technique (CLCVP)
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Acute Kidney Injury (AKI), Controlled Low Central Venous Pressure (CLCVP), Central Venous Pressure (CVP), Postoperative Cognitive Dysfunction (POCD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

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.

no intervention measures

Outcomes

Primary Outcome Measures

Acute kidney injury (AKI) 1
Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL)
Acute kidney injury (AKI) 2
Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL)
Acute kidney injury (AKI) 3
Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL)
Acute kidney injury (AKI) 4
Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL)

Secondary Outcome Measures

Postoperative cognitive dysfunction (POCD) 1
Diagnosis of postoperative POCD using MSE scales
Postoperative cognitive dysfunction (POCD) 2
Diagnosis of postoperative POCD using MSE scales
Postoperative cognitive dysfunction (POCD) 3
Diagnosis of postoperative POCD using MSE scales

Full Information

First Posted
March 21, 2023
Last Updated
May 10, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05855954
Brief Title
Application of CLCVP Technique in Early Intervention of CSA-AKI
Official Title
Application of Controlled Low Central Venous Pressure Technique in Early Intervention of Cardiac Surgery-associated Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute Kidney Injury (AKI), Controlled Low Central Venous Pressure (CLCVP), Central Venous Pressure (CVP), Postoperative Cognitive Dysfunction (POCD)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention measures
Intervention Type
Combination Product
Intervention Name(s)
controlled low central venous pressure technique (CLCVP)
Intervention Description
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 Outcome Measure Information:
Title
Acute kidney injury (AKI) 1
Description
Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL)
Time Frame
preoperation, every day for 7 days after surgery
Title
Acute kidney injury (AKI) 2
Description
Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL)
Time Frame
one day after surgery
Title
Acute kidney injury (AKI) 3
Description
Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL)
Time Frame
three days after surgery
Title
Acute kidney injury (AKI) 4
Description
Diagnosis of acute kidney injury by detecting serum creatinine levels and neutrophil gelatinase associated lipid carrier protein (NGAL)
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
Postoperative cognitive dysfunction (POCD) 1
Description
Diagnosis of postoperative POCD using MSE scales
Time Frame
preoperation
Title
Postoperative cognitive dysfunction (POCD) 2
Description
Diagnosis of postoperative POCD using MSE scales
Time Frame
7 days after surgery
Title
Postoperative cognitive dysfunction (POCD) 3
Description
Diagnosis of postoperative POCD using MSE scales
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210012
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35249707
Citation
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.
Results Reference
result
PubMed Identifier
33549321
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;126(3):599-607. doi: 10.1016/j.bja.2020.12.028. Epub 2021 Feb 4.
Results Reference
result
PubMed Identifier
25387727
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: assessment of 2116 cases. HPB (Oxford). 2015 Mar;17(3):258-64. doi: 10.1111/hpb.12347. Epub 2014 Nov 11.
Results Reference
result
PubMed Identifier
34343737
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 1.
Results Reference
result

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Application of CLCVP Technique in Early Intervention of CSA-AKI

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