N/A
N=16
Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial
Esophageal Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT02033213 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) — 345.01; 330.11; 315.51; 307.11 mmHg — p=0.410
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restrictive group (Other); Liberal group (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Klinički Bolnički Centar Zagreb
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) |
345.01; 330.11; 315.51; 307.11 | 0.410 |
| PRIMARY Creatinine Values During and After Esophageal Carcinoma Surgery |
91.91; 90.88; 93.51; 100.88 | 0.791 |
| PRIMARY Lactate Values During and After Esophageal Carcinoma Surgery |
3.93; 3.26; 2.69; 2.40 | 0.322 |
| PRIMARY Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management. |
3.93; 3.26; 2.69; 2.40 | 0.030 sig |
| SECONDARY Duration of Surgery |
275.61; 324.41 | 0.362 |
| SECONDARY Total Volume of Administered Intraoperative Fluid |
2823.75; 3960.00 | 0.020 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02033213). 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.