Goal Directed TherapyGDT-thoraxNCT03245372

Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study).

A study testing Goal directed therapy in people with Goal Directed Therapy and Fluid Therapy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

Completed

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

Official record

Search all trials

Trial summary

The primary aim of this study is to quantify and compare the hemodynamic control of cardiac index in patients who receive either goal-directed therapy or standard hemodynamic management in lung resection surgery Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Goal Directed Therapy, Fluid Therapy
What is being tested?: Goal directed therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteSpain
Study dates: 10 Oct 2017to 30 Sep 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults patients ( 18 years old)
Written informed consent
Elective lung resection surgery (open or thoracoscopic lung lobectomy)

Who cannot join

Severe obesity
Moderate to severe aortic insufficiency
Renal failure requiring hemodialysis
Left ventricle ejection fraction less than 35 %
Urgent surgery

Trial locations and contacts

1 site in 1 country.

Spain1 site

University hospital Virgen del Rocío
Seville, 41013

Other trials in Spain

About this study

Official title: Goal Directed Therapy Versus Standard Care in Lung Resection Surgery, a Randomized, Controlled Trial (GDT-thorax Study).

Read the detailed description

The investigators hypothesize that the percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2 is higher in goal directed therapy

Conditions: Goal Directed Therapy, Fluid Therapy
Being tested: Standard care, Goal directed therapy
Keywords: cardiac output, perioperative care, postoperative complications
Medical subject headings: Postoperative Complications

What participants receive

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

Standard careProcedure or surgery
Also called Conventional fluid and hemodynamic management
Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation).
Goal directed therapyProcedure or surgery
Also called Goal directed fluid and hemodynamic management
The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.

Study groups in NCT03245372
Study group	Role	What they receive
Standard care	Active comparator	Basic intraoperative hemodynamic objectives Receives: Procedure: Standard care
Goal directed therapy	Experimental	Target value is a cardiac index equal or superior to 2.2 l/min/m2. Receives: Procedure: Goal directed therapy

What is being measured

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

Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)
To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2.
Measured: During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.

Secondary outcomes (8)

Tissue Perfusion Marker: Lactate
To compare lactate in the first 24 hours in both groups
Measured: Within 24 hours after lung surgery
Tissue Perfusion Marker: SvcO2
To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups
Measured: Within 24 hours after lung surgery
Oxygenation Marker: PaO2/FiO2 Ratio
To compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups
Measured: Within 24 hours after lung surgery
Fluid Balance
To compare fluid balance (differences between the amount of water taken into the body and the amount excreted or lost) in the first 24 hours in both groups
Measured: After 24 hours of finalization of lung surgery
Observation of Acute Kidney Injury (AKI)
To compare the Number of Participants with Acute Kidney Injury in both groups
Measured: After 72 hours of finalization of lung surgery
Observation of Acute Respiratory Distress Syndrome (ARDS)
To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups
Measured: Within 30 days after lung surgery
Duration of Hospital Stay
To compare hospital stay in both groups
Measured: Within 30 days after lung surgery
Mortality
To compare the mortality rate in both groups
Measured: Within 30 days after lung surgery

Timeline

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

10 Oct 201730 Sep 2018

First posted10 Aug 2017
Study start10 Oct 2017
Primary completion23 Mar 2018
Study completion30 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Goal Directed TherapyStudies of the same condition, open and under way.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03245372
Sponsor's protocol ID: 2017/118
Acronym: GDT-thorax
Status last verified: Oct 2021
First submitted: 17 Jul 2017
Last updated: 20 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Yes. Anonymized data for individual patient data is planned to be shared with all participants within 6 months of data completion

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
Recruiting
Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery
Surgery Complications
Not yet recruiting
Passive Versus Active Music Therapy Parkinson's Disease
Parkinson Disease (PD)
Recruiting
Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)
Diabetic Kidney Disease (DKD), Type 2 Diabetes Mellitus (T2DM)

All Goal Directed Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Goal Directed Therapy Versus Standard Care in Lung Resection Surgery, a Randomized, Controlled Trial (GDT-thorax Study).
ClinicalTrials.gov ID: NCT03245372
Acronym / sponsor ID: GDT-thorax / 2017/118
Conditions: Goal Directed Therapy, Fluid Therapy
Keywords: cardiac output, perioperative care, postoperative complications
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
Study start: 10 Oct 2017 (actual)
Primary completion: 23 Mar 2018 (actual)
Study completion: 30 Sep 2018 (actual)
First posted: 10 Aug 2017 (actual)
Results: Posted 20 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The investigators hypothesize that the percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2 is higher in goal directed therapy

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard care	Active comparator	Procedure: Standard careBasic intraoperative hemodynamic objectives
Goal directed therapy	Experimental	Procedure: Goal directed therapyTarget value is a cardiac index equal or superior to 2.2 l/min/m2.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults patients ( 18 years old)
Written informed consent
Elective lung resection surgery (open or thoracoscopic lung lobectomy)

Key exclusion criteria (5 listed)

Severe obesity
Moderate to severe aortic insufficiency
Renal failure requiring hemodialysis
Left ventricle ejection fraction less than 35 %
Urgent surgery

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
Standard careAlso: Conventional fluid and hemodynamic managementHeart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation).	Procedure or surgery	Standard care
Goal directed therapyAlso: Goal directed fluid and hemodynamic managementThe hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.	Procedure or surgery	Goal directed therapy

Primary outcome

Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)
Time frame: During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.
To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2.

8 secondary outcomes

Tissue Perfusion Marker: Lactate
Time frame: Within 24 hours after lung surgery
Tissue Perfusion Marker: SvcO2
Time frame: Within 24 hours after lung surgery
Oxygenation Marker: PaO2/FiO2 Ratio
Time frame: Within 24 hours after lung surgery
Fluid Balance
Time frame: After 24 hours of finalization of lung surgery
Observation of Acute Kidney Injury (AKI)
Time frame: After 72 hours of finalization of lung surgery
Observation of Acute Respiratory Distress Syndrome (ARDS)
Time frame: Within 30 days after lung surgery
Duration of Hospital Stay
Time frame: Within 30 days after lung surgery
Mortality
Time frame: Within 30 days after lung surgery

Results and safety

Results posted to the registry on 20 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Care	15	15
Goal Directed Therapy	15	15

Primary outcome: Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)

Time frame: During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.. Median (Inter-Quartile Range). Unit: percentage of time

Measure	Standard Care n = 15	Goal Directed Therapy n = 15
Value	97 (92 to 99)	91 (79 to 98)

Standard Care vs Goal Directed Therapy: p = 0.114, Wilcoxon (Mann-Whitney)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Care	3 of 15 (20%)	12 of 15 (80%)	1 of 15
Goal Directed Therapy	4 of 15 (26.7%)	14 of 15 (93.3%)	0 of 15

Limitations and caveats (from the sponsor): This is a pilot study and the clinician (anesthesiologist) who performed the anesthetic procedure had to know the assignment of the arm. The intervention was limited to the intraoperative period. Postoperative morbidity and mortality surveillance was limited to one month. The study, therefore, was not designed to have sufficient power to detect significant differences in major postoperative complications.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Yes. Anonymized data for individual patient data is planned to be shared with all participants within 6 months of data completion

Related trials for Goal Directed Therapy

Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
Recruiting
Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery
Surgery Complications
Not yet recruiting
Passive Versus Active Music Therapy Parkinson's Disease
Parkinson Disease (PD)
Recruiting
Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD)
Diabetic Kidney Disease (DKD), Type 2 Diabetes Mellitus (T2DM)

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.

Manuel Bertomeu, MD-PhD study chair

Andaluz Health Service

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Goal directed therapy in people with Goal Directed Therapy and Fluid Therapy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

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 3 inclusion and 5 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 20 Oct 2021. 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 Spain. 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?

Yes. Results are posted in the registry (first posted 20 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) (time frame: During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.). 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 NCT03245372.

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 20 Oct 2021.