General AnesthesiaNCT02003066
Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection
A study testing Standard fluid therapy and Conservative fluid therapy in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Standard fluid therapy and Conservative fluid therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2014to 8 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients of age over 20 years scheduled for free flap reconstruction after head and neck cancer resection
Who cannot join
- valvular heart disease
- congestive heart failure
- liver failure
- renal failure
- pregnant woman
- allergy to hydroxyethyl starch solutions
- coagulation abnormalities
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University Health System
Seoul, 120-752
About this study
Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Investigators will compare the effect of goal-directed fluid therapy using stroke volume variation on recovery in patients undergoing free flap reconstruction after head and neck cancer resection.
- Conditions
- General Anesthesia
- Being tested
- Standard fluid therapy, Conservative fluid therapy
- Keywords
- Fluid Therapy, Head and Neck Neoplasms, Surgical Flaps
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard fluid therapyProcedure or surgery
In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.
Conservative fluid therapyProcedure or surgery
In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Experimental | Not described Receives: Procedure: Standard fluid therapy |
| Conservative | Active comparator | Not described Receives: Procedure: Conservative fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study start20 Mar 2014
- Primary completion8 Mar 2016
- Study completion8 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003066
- Sponsor's protocol ID
- 4-2013-0638
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2013
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim HJ, Kim EJ, Lee HJ, Min JY, Kim TW, Choi EC, Kim WS, Koo BN. Effect of goal-directed haemodynamic therapy in free flap reconstruction for head and neck cancer. Acta Anaesthesiol Scand. 2018 Aug;62(7):903-914. doi: 10.1111/aas.13100. Epub 2018 Mar 25.
PubMed 29574681
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection
- ClinicalTrials.gov ID
- NCT02003066
- Acronym / sponsor ID
- 4-2013-0638
- Conditions
- General Anesthesia
- Keywords
- Fluid Therapy, Head and Neck Neoplasms, Surgical Flaps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 Mar 2014 (actual)
- Primary completion
- 8 Mar 2016 (actual)
- Study completion
- 8 Mar 2016 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Investigators will compare the effect of goal-directed fluid therapy using stroke volume variation on recovery in patients undergoing free flap reconstruction after head and neck cancer resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Experimental | Procedure: Standard fluid therapy |
| Conservative | Active comparator | Procedure: Conservative fluid therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients of age over 20 years scheduled for free flap reconstruction after head and neck cancer resection
Key exclusion criteria (7 listed)
- valvular heart disease
- congestive heart failure
- liver failure
- renal failure
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard fluid therapyIn Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg. | Procedure or surgery | Standard |
| Conservative fluid therapyIn Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine. | Procedure or surgery | Conservative |
Primary outcome
Length of hospital stay
Time frame: 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Derived from this study: PubMed 29574681Kim HJ, Kim EJ, Lee HJ, Min JY, Kim TW, Choi EC, Kim WS, Koo BN. Effect of goal-directed haemodynamic therapy in free flap reconstruction for head and neck cancer. Acta Anaesthesiol Scand. 2018 Aug;62(7):903-914. doi: 10.1111/aas.13100. Epub 2018 Mar 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard fluid therapy and Conservative fluid therapy in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.