Preoperative Goal-directed Fluid Therapy and Physiological Changes Following One-lung Ventilation

March 7, 2017 updated by: National Taiwan University Hospital

Does Preoperative Maximization Fluid Strategies for Goal-directed Therapy Affect Physiological Changes Following One-lung Ventilation

Intraoperative goal-directed fluid therapy (GDFT) is proposed to improve the outcomes of patients undergoing major surgery. In the GDFT algorithm, the employment of fluid bolus plays a crucial role. Dynamic fluid responsiveness parameters, such as stroke volume (SV) response to fluid infusion, are precise fluid indicators that specifically determine patient volume status and are helpful for clinicians to determine the appropriate time for fluid bolus. In this study, we compared two fluid strategies guided by SV response, namely maximization and nonmaximization protocols, during intraoperative GDFT for patients undergoing thoracic surgery requiring one-lung ventilation. Clinical outcomes and perioperative changes in serum biomarkers of oxidative injury were compared between the two groups as the primary and secondary outcomes respectively.

Study Overview

Status

Status

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

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

Intraoperative goal-directed fluid therapy (GDFT) is proposed to improve the outcomes of patients undergoing major surgery. In the GDFT algorithm, the employment of fluid bolus plays a crucial role. Dynamic fluid responsiveness parameters, such as stroke volume (SV) response and stroke volume variation (SVV), are precise fluid indicators that specifically determine patient volume status and are helpful for clinicians to determine the appropriate time for fluid bolus. During GDFT, fluid is commonly administered to maximize perfusion by maintaining patient blood volume at the plateau portion of the Frank-Starling curve by keeping patient at a lower SV response (i.e., SV increase < 10% and maintained for 20 minutes). However, maximization does not necessarily imply optimization; the role of fluid maximization of perfusion in GDFT remains controversial.Moreover, the importance of intraoperative GDFT in thoracic surgery has rarely been explored, because most intraoperative GDFTs have been conducted during abdominal surgery. Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and mortality after lung resection. Despite the advancement in both the surgical techniques and the perioperative management, the incidence of postoperative ALI remains remarkable. Risk factors are evident, including preoperative pulmonary function, type of surgical procedure, intraoperative fluid management, one-lung ventilation, and ventilator settings. Fluid management for thoracic surgery is challenging. Evidence has shown the association between excessive fluid administration and development of acute lung injury. Therefore, fluid restriction may benefit patients undergoing thoracic surgery. By contrast, restrictive fluid management incurs risks such as a hypovolemic state with impaired tissue perfusion which may result in organ dysfunction and in particular postoperative acute kidney injury. Accordingly, maintenance of perfusion through a maximized fluid protocol may be favorable. However, this debate has not yet been investigated.In this study, two fluid strategies guided by SV response, namely maximization and nonmaximization protocols, during intraoperative GDFT for patients undergoing thoracic surgery requiring one-lung ventilation. Clinical outcomes and perioperative changes in serum biomarkers of oxidative injury were compared between the two groups as the primary and secondary outcomes respectively.

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.
Interventional

Enrollment (Anticipated)

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.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ya-Jung Cheng, MD, PhD
  • Phone Number: 65523 +886-2-2312-3456
  • Email: chengyj@ntu.edu.tw

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Thoracic patients requiring thoracic surgery and lung isolation
  • Age 20 - 70 years old

Exclusion Criteria:

  • Arrhythmia and irregular heart beats
  • End-stage organ disease and difficult to manipulate fluid status
  • Pregnant women

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: SV maximization
Dynamic fluid responsiveness parameters, such as stroke volume (SV) response to fluid therapy, are precise fluid indicators that specifically determine patient volume status and are helpful for clinicians to determine the appropriate time for fluid bolus. For SV maximization, the investigators maximize SV after anesthetic induction by fluid therapy up to achieve maximized SV maintained.
Other: SV maximization
Voluven solution 250 mL infusion per 5 minutes up to the platau of Flank-starling law: status to SV change < 10% and maintained for 20 minutes
No Intervention: SV normalization
NO active fluid therapy.

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
Clinical outcomes (postoperative)
Time Frame: 1 year
collected from chart review including feeding time(hrs postop), hospitalization (days) ICU stay(hrs), any cardiac, pulmonary, and other major organ complications up to 12 months
1 year
intraoperative physiological changes and managements
Time Frame: 1day
collected from anesthetic record including blood pressure changes(mmHg), data from arterial blood gas, use of vasoconstrictors, etc.,
1day

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
Perioperative oxidative injury biomarkers
Time Frame: 1 day
tests on intraoperative serum sample, including baseline after anesthetic induction, during one lung ventilation, and resuming two lung ventilation
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.
National Taiwan University 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: Ya-Jung Cheng, MD, PhD, National Taiwan University 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 (Anticipated)

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.
March 15, 2017

Primary Completion (Anticipated)

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.
December 31, 2017

Study Completion (Anticipated)

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.
December 31, 2017

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).
February 1, 2017

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.
February 21, 2017

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.
February 27, 2017

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.
March 8, 2017

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.
March 7, 2017

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.
January 1, 2017

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.
  • 201605133RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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