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

NCT03064880 | Unknown

• 1 other identifier: 201605133RINB
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Therapy Adverse Effect

Keywords

Thoracic surgery; Fluid responsiveness; Hemodynamics; Oxidative stress; Goal-directed fluid therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Perioperative oxidative injury biomarkers

  1 day

Study Arms (2)

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.

Other: SV maximization

SV normalization

NO INTERVENTION

NO active fluid therapy.

Interventions

SV maximization OTHER

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

SV maximization

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Officials

• Ya-Jung Cheng, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Jung Cheng, MD, PhD

CONTACT

+886-2-2312-3456; chengyj@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 27, 2017
• Study Start: March 15, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 8, 2017

Record last verified: 2017-01