Therapy Adverse EffectNCT03064880
Preoperative Goal-directed Fluid Therapy and Physiological Changes Following One-lung Ventilation
A study testing SV maximization in people with Therapy Adverse Effect, run by National Taiwan University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Therapy Adverse Effect
- What is being tested?
- SV maximization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thoracic patients requiring thoracic surgery and lung isolation
- Age 20 - 70 years old
Who cannot join
- Arrhythmia and irregular heart beats
- End-stage organ disease and difficult to manipulate fluid status
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Therapy Adverse Effect
- Being tested
- SV maximization
- Keywords
- Thoracic surgery, Fluid responsiveness, Hemodynamics, Oxidative stress, Goal-directed fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SV maximizationOther
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
| Study group | Role | What they receive |
|---|---|---|
| SV maximization | Active comparator | 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. Receives: Other: SV maximization |
| SV normalization | No intervention | NO active fluid therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes (postoperative)
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
Measured: 1 year
intraoperative physiological changes and managements
collected from anesthetic record including blood pressure changes(mmHg), data from arterial blood gas, use of vasoconstrictors, etc.,
Measured: 1day
Secondary outcomes (1)
Perioperative oxidative injury biomarkers
tests on intraoperative serum sample, including baseline after anesthetic induction, during one lung ventilation, and resuming two lung ventilation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start15 Mar 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapy Adverse EffectStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Jung Cheng, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064880
- Sponsor's protocol ID
- 201605133RINB
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2017
- Last updated
- 8 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preoperative Maximization Fluid Strategies for Goal-directed Therapy Affect Physiological Changes Following One-lung Ventilation
- ClinicalTrials.gov ID
- NCT03064880
- Acronym / sponsor ID
- 201605133RINB
- Conditions
- Therapy Adverse Effect
- Keywords
- Thoracic surgery, Fluid responsiveness, Hemodynamics, Oxidative stress, Goal-directed fluid therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SV maximization | Active comparator | Other: SV maximizationDynamic 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. |
| SV normalization | No intervention | –NO active fluid therapy. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thoracic patients requiring thoracic surgery and lung isolation
- Age 20 - 70 years old
Key exclusion criteria (3 listed)
- Arrhythmia and irregular heart beats
- End-stage organ disease and difficult to manipulate fluid status
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SV maximizationVoluven 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 | Other | SV maximization |
Primary outcome
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
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.,
1 secondary outcome
Perioperative oxidative injury biomarkers
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Jung Cheng, MD, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing SV maximization in people with Therapy Adverse Effect, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Jung Cheng, MD, PhD (+886-2-2312-3456 ext. 65523, chengyj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes (postoperative) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.