Central Venous Pressure Monitoring and Prognosis of High-risk Operating Patients

October 15, 2020 updated by: Xiuling Shang, Fujian Provincial Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who were in pregnancy. ⑵Older than 80 years. ⑶Underwent cardiac surgery or had chronic kidney disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group A
Patients with the initial central venous pressure(CVP1) <8 mm Hg
Other: no intervention measures
Because this study was a retrospective study, no intervention measures were implemented for the patients enrolled.
Group B
Patients with 8≤CVP1≤12mm Hg
Other: no intervention measures
Because this study was a retrospective study, no intervention measures were implemented for the patients enrolled.
Group C
Patients with CVP1>12 mm Hg
Other: no intervention measures
Because this study was a retrospective study, no intervention measures were implemented for the patients enrolled.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 28-day
28-day mortality, length of stay in intensive care unit and hospitalization, surgical complications
28-day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 1-day
Comparison of perioperative fluid management in each group
1-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Provincial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiafang Wu, M.D., Department of Critical Care Medicine, Fujian Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K2018-09-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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