N/A
N=30
Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study).
Goal Directed Therapy · Fluid Therapy
Bottom Line
View on ClinicalTrials.gov: NCT03245372 ↗Enrolled (actual)
30
Serious AEs
23.3%
Results posted
Oct 2021
Primary outcome: Primary: Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) — 97; 91 percentage of time — p=0.114
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard care (Procedure); Goal directed therapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) |
97; 91 | 0.114 |
| SECONDARY Tissue Perfusion Marker: Lactate |
0.70; 0.80 | 0.692 |
| SECONDARY Tissue Perfusion Marker: SvcO2 |
66.03; 70.16 | 0.082 |
| SECONDARY Oxygenation Marker: PaO2/FiO2 Ratio |
331.43; 339.05 | 0.443 |
| SECONDARY Fluid Balance |
647.17; 748.83 | 0.668 |
| SECONDARY Observation of Acute Kidney Injury (AKI) |
3; 5 | 0.516 |
| SECONDARY Observation of Acute Respiratory Distress Syndrome (ARDS) |
0; 0 | — |
| SECONDARY Duration of Hospital Stay |
4; 5 | 0.229 |
| SECONDARY Mortality |
1; 0 | 1 |
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
Eligibility Criteria
Inclusion Criteria
- Adults patients ( 18 years old)
- Written informed consent
- Elective lung resection surgery (open or thoracoscopic lung lobectomy)
Exclusion Criteria
- Severe obesity
- Moderate to severe aortic insufficiency
- Renal failure requiring hemodialysis
- Left ventricle ejection fraction less than 35 %
- Urgent surgery
Data sourced from ClinicalTrials.gov (NCT03245372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.