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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03245372
Other study ID # 2017/118
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2017
Est. completion date September 30, 2018

Study information

Verified date October 2021
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date September 30, 2018
Est. primary completion date March 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Standard care
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 therapy
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.

Locations

Country Name City State
Spain University hospital Virgen del Rocío Sevilla

Sponsors (1)

Lead Sponsor Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 Tissue Perfusion Marker: Lactate To compare lactate in the first 24 hours in both groups Within 24 hours after lung surgery
Secondary Tissue Perfusion Marker: SvcO2 To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups Within 24 hours after lung surgery
Secondary 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 Within 24 hours after lung surgery
Secondary 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 After 24 hours of finalization of lung surgery
Secondary Observation of Acute Kidney Injury (AKI) To compare the Number of Participants with Acute Kidney Injury in both groups After 72 hours of finalization of lung surgery
Secondary Observation of Acute Respiratory Distress Syndrome (ARDS) To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups Within 30 days after lung surgery
Secondary Duration of Hospital Stay To compare hospital stay in both groups Within 30 days after lung surgery
Secondary Mortality To compare the mortality rate in both groups Within 30 days after lung surgery
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