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Goal-directed Fluid TherapyNCT03237351

Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection

A study testing Fluid therapy in people with Goal-directed Fluid Therapy, run by ZhiHeng Liu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Perioperative fluid management is a key component of anesthetic management during thoracic surgery. On one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Goal-directed Fluid Therapy
What is being tested?
Fluid therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Sep 2017to 1 Mar 2020
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists physical status I-III; aged 18-60 years old; BMI 18.5 ~ 28 kg/m2

Who cannot join

  • Refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte disturbance before operation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518035

Other trials in China

About this study

Official title: Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection: a Randomized Controlled Trial

Perioperative fluid management is a key component of anesthetic management during thoracic surgery. On one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary complications, notably pulmonary edema, which carries a high mortality rate. Perioperative fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed. Therefore, to achieve the balance between preventing fluid overload and optimising organ perfusion, the practical index to guide fluid management, which can predict whether fluid loading will improve haemodynamic conditions in an individual patient, would be very valuable during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory variations of arterial pressure [i.e. pulse pressure variation (PPV) and systolic pressure variation] can predict fluid responsiveness in mechanically ventilated patients under various conditions. Therefore, pressure variations are increasingly being advocated for fluid management.This study will discuss the effects of pulse pressure variation(PPV) in different level during anesthesia on patients with oxygenation index and short-term prognosis undergoing video-assisted thoracoscopic surgery for pneumoresection.

Being tested
Fluid therapy
Keywords
goal-directed fluid therapy, thoracic surgery, video-assisted, acute lung injury
Medical subject headings
Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluid therapyDevice

    Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Study groups in NCT03237351
Study groupRoleWhat they receive
Conventional therapy groupActive comparatorPatients in Conventional therapy group were received fluid therapy: intraoperative transfusion volume=maintenance fluids+deficit replacement+restoration of losses and with heart rate, mean arterial pressure, urine measurement ect.
Receives: Device: Fluid therapy
Low value of PPV groupExperimentalPatients in low value of PPV group were received fluid therapy according to PPV (3% ≤PPV < 5%) .
Receives: Device: Fluid therapy
High value of PPV groupExperimentalPatients in high value of PPV group were received fluid therapy according to PPV (5% ≤PPV < 8%) .
Receives: Device: Fluid therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Oxygenation Index in 48 hours

    Measured: Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation

Secondary outcomes (12)

  1. The duration of surgery

    Measured: During surgery period

  2. The duration of mechanical ventilation

    Measured: During surgery period

  3. Crystalloid administered

    Measured: During surgery period

  4. Colloid administered

    Measured: During surgery period

  5. Blood loss

    Measured: During surgery period

  6. Urine output

    Measured: During surgery period

  7. Number of patients received vasopressor

    Measured: During surgery period

  8. Blood pressure

    Measured: Before the surgery and 48 hours after surgery

  9. Leukocyte

    Measured: Before the surgery and 48 hours after surgery

  10. Hematocrit

    Measured: Before the surgery and 48 hours after surgery

  11. Complication until hospital discharge

    Measured: 1 month after surgery

  12. Hospital stay postoperatively

    Measured: 1 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2017
  2. Study start1 Sep 2017
  3. Primary completion1 Jan 2020
  4. Study completion1 Mar 2020

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03237351
Sponsor's protocol ID
2017041102
Status last verified
Apr 2020
First submitted
24 Jul 2017
Last updated
22 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.

    PubMed 19837807

  • Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.

    PubMed 19602972

  • Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.

    PubMed 26440438

  • Chau EH, Slinger P. Perioperative fluid management for pulmonary resection surgery and esophagectomy. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):36-44. doi: 10.1177/1089253213491014. Epub 2013 May 29.

    PubMed 23719773

  • Zhang J, Chen CQ, Lei XZ, Feng ZY, Zhu SM. Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study. Clinics (Sao Paulo). 2013 Jul;68(7):1065-70. doi: 10.6061/clinics/2013(07)27.

    PubMed 23917675

  • Lee JH, Jeon Y, Bahk JH, Gil NS, Hong DM, Kim JH, Kim HJ. Pulse pressure variation as a predictor of fluid responsiveness during one-lung ventilation for lung surgery using thoracotomy: randomised controlled study. Eur J Anaesthesiol. 2011 Jan;28(1):39-44. doi: 10.1097/EJA.0b013e32834089cf.

    PubMed 21088596

Questions about this trial

What is this clinical trial studying?

A study testing Fluid therapy in people with Goal-directed Fluid Therapy, run by ZhiHeng Liu at 1 site in China.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Oxygenation Index in 48 hours (time frame: Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03237351, which also lists 6 linked publications.

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 22 Apr 2020.

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