Clinical trial · Interventional
Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators
NCT01320891CI-TRIAL-00027418completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aim of the study is to ascertain whether a different strategy of fluids administration can be responsible of differences in terms of acid/base disorders (Stewart approach), pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated either with not-balanced solutions (Normal Saline) or balanced solutions
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large Bowel Cancer | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| balanced solutions | Behavioral | — | UNRESOLVED |
| not balanced | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- balanced
- description
- arm in which the subjects received only balanced solutions
- interventionNames
- Behavioral: balanced solutions
- type
- EXPERIMENTAL
- label
- not balanced
- description
- arm in which the subjects received only not balanced solutions that means only normal saline and colloid dissolved in normal saline
- interventionNames
- Behavioral: not balanced
Primary outcomes (1)
- measure
- acid/base disorder
- timeFrame
- T0: anaesthesia induction (control value) T1: end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of large bowel cancer * Age \> 18 years old Exclusion Criteria: Emergency surgery for bowel punch or intestinal occlusion * Massive bleeding * Therapy with corticosteroid or nonsteroid antiinflammatory substances * Renal insufficiency (serum creatinine \> 200 micromol /l) * Cardiac insufficiency (NYHA III-IV) * Altered liver function (ALT \> 40 U/l AST \>40 U/l) * Preoperative anaemia ( Hb \< 10 g/dl ) * Allergy to hydrossietilic starches * Patient rejection to share the study
References
Publications (1)
- DERIVEDVolta CA, Trentini A, Farabegoli L, Manfrinato MC, Alvisi V, Dallocchio F, Marangoni E, Alvisi R, Bellini T. Effects of two different strategies of fluid administration on inflammatory mediators, plasma electrolytes and acid/base disorders in patients undergoing major abdominal surgery: a randomized double blind study. J Inflamm (Lond). 2013 Sep 24;10(1):29. doi: 10.1186/1476-9255-10-29. PMID 24059479