Central Venous PressureNCT04596332
Central Venous Pressure Monitoring and Prognosis of High-risk Operating Patients
An observational study of Central Venous Pressure, run by Fujian Provincial Hospital.
Trial summary
While central venous pressure measurement is used to guide fluid management in high risk surgical patients during perioperative period, the relationship between the value of central venous pressure and organ dysfunction and prognosis of high-risk operating patients is unknow. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Central Venous Pressure
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2014to 30 Mar 2020
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a single-center, retrospective, observational study enrolled 196 patients undergoing high-risk surgery who admitted to surgical intensive care unit(SICU) directly after operation from Feb 1,2014 to Mar 31,2018.
Who may be able to join
- Age ≥18 years.⑵ All patients undergoing surgery and admitted to our intensive care unit (ICU) directly after surgery were enrolled into the respective study.⑶ They stayed in the ICU more than 48 hours with central venous pressure monitored for more than 48 hours.
Who cannot join
- Patients who were in pregnancy. ⑵Older than 80 years. ⑶Underwent cardiac surgery or had chronic kidney disease.
About this study
Official title: Central Venous Pressure Monitoring is Associated With Improved Prognosis of High-risk Operating Patients During Perioperative Period
While central venous pressure measurement is used to guide fluid management in high risk surgical patients during perioperative period, the relationship between the value of central venous pressure and organ dysfunction and prognosis of high-risk operating patients is unknow. In this study, we conducted a retrospective study of the relationship between the initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU stay, and prognosis of critically ill patients.
Read the detailed description
Although less than 15% of high-risk patients (elderly or with limited cardiopulmonary reserves) undergo surgery, these patients account for 80% of hospital deaths. The requirements for hemodynamic monitoring to critical patients during perioperative period reach are of maximal importance, for two major reasons: (i) absolute or relative volume deficiency often occurs in postoperative patients due to preoperative fasting, intraoperative bleeding and non-dominant fluid loss caused by vasodilation and fluid redistribution caused by anesthesia; (ii) insufficient fluid replacement may lead to increased postoperative organ complications and poor wound healing. Adequate and goal-oriented hemodynamic monitoring combined with early and appropriate treatment can improve the prognosis of high-risk surgical patients.
Central venous pressure is a localized parameter of the superior vena cava or the right atrium and is closely related to the right ventricular end-diastolic pressure. With volume overload, CVP levels may be abnormally elevated. Maintaining central venous pressure as low as possible is conducive to the recovery of internal organs during haemodynamic treatment, especially for the kidney, intestine, and brain, etc. However, elevated central venous pressure (CVP) occurs frequently in critical care settings, including postoperative critical patients. In this study, we conducted a retrospective study of the relationship between the initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU stay, and prognosis of critically ill patients.
- Conditions
- Central Venous Pressure
- Being tested
- no intervention measures
- Keywords
- perioperative, central venous pressure, fluid management, acute renal injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention measuresOther
Because this study was a retrospective study, no intervention measures were implemented for the patients enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with the initial central venous pressure(CVP1) <8 mm Hg Receives: Other: no intervention measures | |
| Group B | Patients with 8≤CVP1≤12mm Hg Receives: Other: no intervention measures | |
| Group C | Patients with CVP1>12 mm Hg Receives: Other: no intervention measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
28-day mortality, length of stay in intensive care unit and hospitalization, surgical complications
Measured: 28-day
Secondary outcomes (1)
Secondary Outcome
Comparison of perioperative fluid management in each group
Measured: 1-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Feb 2014
- Primary completion31 Mar 2018
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous PressureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 196 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuling Shang, Fujian Provincial Hospital
- Investigators
- Jiafang Wu, M.D., Principal investigator, Department of Critical Care Medicine, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596332
- Sponsor's protocol ID
- K2018-09-006
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Pressure Monitoring is Associated With Improved Prognosis of High-risk Operating Patients During Perioperative Period
- ClinicalTrials.gov ID
- NCT04596332
- Acronym / sponsor ID
- K2018-09-006
- Conditions
- Central Venous Pressure
- Keywords
- perioperative, central venous pressure, fluid management, acute renal injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 22 Oct 2020 (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.
While central venous pressure measurement is used to guide fluid management in high risk surgical patients during perioperative period, the relationship between the value of central venous pressure and organ dysfunction and prognosis of high-risk operating patients is unknow. In this study, we conducted a retrospective study of the relationship between the initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU stay, and prognosis of critically ill patients.
Detailed description
Although less than 15% of high-risk patients (elderly or with limited cardiopulmonary reserves) undergo surgery, these patients account for 80% of hospital deaths. The requirements for hemodynamic monitoring to critical patients during perioperative period reach are of maximal importance, for two major reasons: (i) absolute or relative volume deficiency often occurs in postoperative patients due to preoperative fasting, intraoperative bleeding and non-dominant fluid loss caused by vasodilation and fluid redistribution caused by anesthesia; (ii) insufficient fluid replacement may lead to increased postoperative organ complications and poor wound healing. Adequate and goal-oriented hemodynamic monitoring combined with early and appropriate treatment can improve the prognosis of high-risk surgical patients.
Central venous pressure is a localized parameter of the superior vena cava or the right atrium and is closely related to the right ventricular end-diastolic pressure. With volume overload, CVP levels may be abnormally elevated. Maintaining central venous pressure as low as possible is conducive to the recovery of internal organs during haemodynamic treatment, especially for the kidney, intestine, and brain, etc. However, elevated central venous pressure (CVP) occurs frequently in critical care settings, including postoperative critical patients. In this study, we conducted a retrospective study of the relationship between the initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU stay, and prognosis of critically ill patients.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 28 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: no intervention measuresPatients with the initial central venous pressure(CVP1) <8 mm Hg |
| Group B | – | Other: no intervention measuresPatients with 8≤CVP1≤12mm Hg |
| Group C | – | Other: no intervention measuresPatients with CVP1>12 mm Hg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-center, retrospective, observational study enrolled 196 patients undergoing high-risk surgery who admitted to surgical intensive care unit(SICU) directly after operation from Feb 1,2014 to Mar 31,2018.
Key inclusion criteria (1 listed)
- Age ≥18 years.⑵ All patients undergoing surgery and admitted to our intensive care unit (ICU) directly after surgery were enrolled into the respective study.⑶ They stayed in the ICU more than 48 hours with central venous pressure monitored for more than 48 hours.
Key exclusion criteria (1 listed)
- Patients who were in pregnancy. ⑵Older than 80 years. ⑶Underwent cardiac surgery or had chronic kidney disease.
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 |
|---|---|---|
| no intervention measuresBecause this study was a retrospective study, no intervention measures were implemented for the patients enrolled. | Other | Group A, Group B, Group C |
Primary outcome
Primary Outcome
Time frame: 28-day
28-day mortality, length of stay in intensive care unit and hospitalization, surgical complications
1 secondary outcome
Secondary Outcome
Time frame: 1-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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. This study is not recruiting at the moment.
Jiafang Wu, M.D. principal investigator
Department of Critical Care Medicine, Fujian Provincial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Pressure, run by Fujian Provincial Hospital.
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 1 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: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.