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

Therapy Adverse Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03064880
• Other study ID #: 201605133RINB
• Status: Not yet recruiting
• Phase: N/A
• First received: February 1, 2017
• Last updated: March 7, 2017
• Start date: March 15, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2017
• Source: National Taiwan University Hospital
• Contact: Ya-Jung Cheng, MD, PhD
• Phone: +886-2-2312-3456
• Email: chengyj[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Therapy Adverse Effect

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	intraoperative physiological changes and managements	collected from anesthetic record including blood pressure changes(mmHg), data from arterial blood gas, use of vasoconstrictors, etc.,	1day
Secondary	Perioperative oxidative injury biomarkers	tests on intraoperative serum sample, including baseline after anesthetic induction, during one lung ventilation, and resuming two lung ventilation	1 day