NCT04596332

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

4.2 years

First QC Date

October 15, 2020

Last Update Submit

October 15, 2020

Conditions

Keywords

perioperativecentral venous pressurefluid managementacute renal injury

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

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

    28-day

Secondary Outcomes (1)

  • Secondary Outcome

    1-day

Study Arms (3)

Group A

Patients with the initial central venous pressure(CVP1) \<8 mm Hg

Other: no intervention measures

Group B

Patients with 8≤CVP1≤12mm Hg

Other: no intervention measures

Group C

Patients with CVP1\>12 mm Hg

Other: no intervention measures

Interventions

Because this study was a retrospective study, no intervention measures were implemented for the patients enrolled.

Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jiafang Wu, M.D.

    Department of Critical Care Medicine, Fujian Provincial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Critical Care Medicine, Fujian Provincial Hospital

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

February 1, 2014

Primary Completion

March 31, 2018

Study Completion

March 30, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share