- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388995
SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
August 25, 2020 updated by: Yi Liu, Chinese PLA General Hospital
Stroke Volume Variation and Pulse Pressure Variation Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently.
Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP).
The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated.
Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications.
However, the usefulness of dynamic indexes in elderly patients has not been previously investigated.
This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haidian
-
Beijing, Haidian, China, 100853
- Chinese PLA General hospital
-
-
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
Ages Eligible for Study
14 years to 78 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I ~II. 4.BMI 18 ~ 24 kg/m2
Exclusion Criteria:
- 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: observed patients
|
volume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluid responsiveness
Time Frame: immediately after the fluid therapy
|
Fluid responsiveness was defined as an increase in CI ≥15%
|
immediately after the fluid therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 12, 2020
Primary Completion (Anticipated)
August 31, 2020
Study Completion (Anticipated)
August 31, 2020
Study Registration Dates
First Submitted
May 11, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (Actual)
May 15, 2020
Study Record Updates
Last Update Posted (Actual)
August 26, 2020
Last Update Submitted That Met QC Criteria
August 25, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGHAOC202002
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.
Clinical Trials on Fluid Therapy
-
Nordsjaellands HospitalRigshospitalet, Denmark; University of CopenhagenRecruitingFluid Therapy | Fluid OverloadDenmark
-
Centre Hospitalier Universitaire, AmiensRecruitingFluid Therapy | Pharmacodynamics | Fluid Responsiveness | Fluid Challenge | Intravenous FluidsFrance
-
Uppsala UniversityCompletedFluid Therapy | Fluid Overload | Critical CareSweden
-
Erasme University HospitalUnknownFluid Therapy | Fluid and Electrolyte ImbalanceBelgium
-
Assiut UniversityCompleted
-
Rajiv Gandhi Cancer Institute & Research Center...Completed
-
Sociedad Española de Anestesiología, Reanimación...Hospital Clinic of Barcelona; Hospital Universitario La Fe; Hospital Universitario... and other collaboratorsUnknown
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalWithdrawnHemodynamic Monitoring | Fluid Management | Goal-Directed Fluid TherapyTurkey
-
Beijing Anzhen HospitalNot yet recruitingFluid Therapy | Microcirculation
Clinical Trials on volume expansion
-
Brian SchlossTerminatedAtrial Septal DefectUnited States
-
Seoul National University HospitalCompletedFluid ResponsivenessKorea, Republic of
-
Seoul National University HospitalCompletedFluid ResponsivenessKorea, Republic of
-
Hallym University Kangnam Sacred Heart HospitalCompletedLaparoscopic SurgeryKorea, Republic of
-
Yonsei UniversityCompletedCoronary Artery Occlusive DiseaseKorea, Republic of
-
Montreal Heart InstituteCompletedLeft Ventricular Function Diastolic Dysfunction | Fluid ResponsivenessCanada
-
Poitiers University HospitalCompleted
-
University of MonastirCompletedAcute Circulatory FailureTunisia
-
Asan Medical CenterCompletedFluid Responsiveness | Modified Prone PositionKorea, Republic of
-
Hospices Civils de LyonCompleted