Clinical trial · Interventional
Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial
- 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)
Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR) results to a high cancer cure rate and a good functional recovery. However, this long complex procedure is accompanied with considerable complications. Excessive fluid administration during this type of surgery has been connected with poor results. There is growing evidence that goal-directed fluid management (GDFM) might improve the results in high-risk patients. Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume administered to patients undergoing head and neck reconstructive surgery.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goal directed fluid management based on continuous monitoring of stroke volume | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Goal directed fluid management
- interventionNames
- Other: Goal directed fluid management based on continuous monitoring of stroke volume
Primary outcomes (1)
- measure
- The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology
- timeFrame
- Initiation of surgery to end of surgery on average 8-10 hours
Secondary outcomes (1)
- measure
- Incidence of major complication and LOS
- timeFrame
- Post operative day 0 to hospital discharge
- description
- Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 years * Signed informed consent Exclusion Criteria: * History CHF * Severe valvular heart defects, intra cardiac shunts * Irregular heart rhythm * Allergy to hydroxyethyl starch solutions * Coagulation abnormalities (INR\>1.5, aPTT\>40s, platelet count\<100x10 9/L * History of severe bleeding disorders * Renal insufficiency with creatinine \>200Umol/L * Pregnant of nursing women * History of skin disorders that are accompanied by chronic puritis
References
Publications (0)
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