Acute Kidney InjuryNCT05855954
Application of CLCVP Technique in Early Intervention of CSA-AKI
A study of Acute Kidney Injury, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210012
Yali Ge, Doctor, China + 025-52271064, ge_yl@163.com
About this study
Official title: Application of Controlled Low Central Venous Pressure Technique in Early Intervention of Cardiac Surgery-associated Acute Kidney Injury
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.
Read more
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- controlled low central venous pressure technique (CLCVP)
- Keywords
- Acute Kidney Injury (AKI), Controlled Low Central Venous Pressure (CLCVP), Central Venous Pressure (CVP), Postoperative Cognitive Dysfunction (POCD)
- Medical subject headings
- Acute Kidney Injury, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: controlled low central venous pressure technique (CLCVP) |
| control group | No intervention | no intervention measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days after surgery
Secondary outcomes (3)
Postoperative cognitive dysfunction (POCD) 1
Diagnosis of postoperative POCD using MSE scales
Measured: preoperation
Postoperative cognitive dysfunction (POCD) 2
Diagnosis of postoperative POCD using MSE scales
Measured: 7 days after surgery
Postoperative cognitive dysfunction (POCD) 3
Diagnosis of postoperative POCD using MSE scales
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 May 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group and control group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yali Ge, Doctor, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855954
- Sponsor's protocol ID
- ClinicalTrials20230321
- Status last verified
- Oct 2024
- First submitted
- 21 Mar 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35249707Lopez 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.
PubMed 33549321Correa-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.
PubMed 25387727Liu 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.
PubMed 34343737Chen L, Hu L, He Y, Kong S, Liu J, Ding K, Zhang C, Zhu D, Cheng Y, Shi H, Zhou J, Ge Y. Controlled low central venous pressure after cardiopulmonary bypass reduces acute kidney injury following cardiac surgery: a randomized controlled trial. Front Med (Lausanne). 2026 Sep 14;13:1846773. doi: 10.3389/fmed.2026.1846773. eCollection 2026.
PubMed 42807432Cheng 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.
PubMed 41466406
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Controlled Low Central Venous Pressure Technique in Early Intervention of Cardiac Surgery-associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05855954
- Acronym / sponsor ID
- ClinicalTrials20230321
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury (AKI), Controlled Low Central Venous Pressure (CLCVP), Central Venous Pressure (CVP), Postoperative Cognitive Dysfunction (POCD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Combination Product: controlled low central venous pressure technique (CLCVP)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| controlled 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. | Combination product | intervention group |
Primary outcome
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
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
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
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
3 secondary outcomes
Postoperative cognitive dysfunction (POCD) 1
Time frame: preoperation
Postoperative cognitive dysfunction (POCD) 2
Time frame: 7 days after surgery
Postoperative cognitive dysfunction (POCD) 3
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Background: PubMed 35249707Chen 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.
- Background: PubMed 33549321Lopez 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.
- Background: PubMed 25387727Correa-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.
- Background: PubMed 34343737Liu 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.
- Derived from this study: PubMed 42807432Chen L, Hu L, He Y, Kong S, Liu J, Ding K, Zhang C, Zhu D, Cheng Y, Shi H, Zhou J, Ge Y. Controlled low central venous pressure after cardiopulmonary bypass reduces acute kidney injury following cardiac surgery: a randomized controlled trial. Front Med (Lausanne). 2026 Sep 14;13:1846773. doi: 10.3389/fmed.2026.1846773. eCollection 2026.
- Derived from this study: PubMed 41466406Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yali Ge, Doctor study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Kidney Injury, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yali Ge, Doctor (China+025-52271064, ge_yl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (AKI) 1 (time frame: preoperation, Within 7 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05855954, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.