Esophageal Neoplasm Clinical Trial
Official title:
Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial
Verified date | April 2014 |
Source | Klinicki Bolnicki Centar Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | Croatia: Ethics Committee |
Study type | Interventional |
An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.
Status | Completed |
Enrollment | 16 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - esophageal carcinoma - Lewis Tanner procedure (median laparotomy and right thoracotomy) Exclusion Criteria: - younger than 18 years - severe lung disease - chronic renal insufficiency - a physical status classification > III on the American Society of Anesthesiologists (ASA) scale - impossible to perform epidural catheter placement - thoraco-phreno-laparotomy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Croatia | Department of Thoracic surgery "Jordanovac" University Hospital Centre Zagreb | Zagreb | City of Zagreb |
Lead Sponsor | Collaborator |
---|---|
Klinicki Bolnicki Centar Zagreb |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) | At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately. | 10 minutes, 6 hours | No |
Primary | Creatinine Values During and After Esophageal Carcinoma Surgery | At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately. | 10 minutes, 6 hours | No |
Primary | Lactate Values During and After Esophageal Carcinoma Surgery | At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately. | 10 minutes, 6 hours | No |
Primary | Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management. | At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive). | 10 minutes, 6 hours | No |
Secondary | Duration of Surgery | Total time of Lewis-Tanner procedure will be measured and compared between two groups. | End of surgery. | No |
Secondary | Total Volume of Administered Intraoperative Fluid | Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups. | End of surgery | No |
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