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

Sponsor
Fujian Provincial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04596332
Collaborator
(none)
196
73.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention measures

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
196 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Central Venous Pressure Monitoring is Associated With Improved Prognosis of High-risk Operating Patients During Perioperative Period
Actual Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Mar 31, 2018
Actual Study Completion Date :
Mar 30, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome [28-day]

    28-day mortality, length of stay in intensive care unit and hospitalization, surgical complications

Secondary Outcome Measures

  1. Secondary Outcome [1-day]

    Comparison of perioperative fluid management in each group

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fujian Provincial Hospital

Investigators

  • Principal Investigator: Jiafang Wu, M.D., Department of Critical Care Medicine, Fujian Provincial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiuling Shang, Department of Critical Care Medicine, Fujian Provincial Hospital, Fujian Provincial Hospital
ClinicalTrials.gov Identifier:
NCT04596332
Other Study ID Numbers:
  • K2018-09-006
First Posted:
Oct 22, 2020
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiuling Shang, Department of Critical Care Medicine, Fujian Provincial Hospital, Fujian Provincial Hospital

Study Results

No Results Posted as of Oct 22, 2020