Postoperative ComplicationsNCT03218540
Stroke Volume Variation vs Central Venous Pressure Guidance Fluid Management in Endovascular Aortic Repair
A study testing Fluid management protocol in people with Postoperative Complications, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central venous pressure (CVP), guidance results in better clinical outcomes. Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine level. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Fluid management protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2017to 31 Jul 2017
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-80 years old
- Patient had aortic aneurysm both thoracic and abdominal types
- Scheduled for elective EVAR procedures
- New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
- Body mass index (BMI) 18-24 kg/m2
- Provided informed consent before surgery
Who cannot join
- Scheduled for emergency or redo surgery
- Received prior fluid therapy (>2,500 ml/day over the 48 h before the surgery)
- Presence of congenital heart disease, cardiomyopathy, rheumatic heart disease, or significant arrhythmia or cardiopulmonary dysfunction, or significant renal or liver diseases
- Preoperative use of vasoactive drugs (e.g. digoxin, nitroglycerine, nifedipine) for ≥3 months
- Difficulty (or contraindication to) placing a central venous catheter
- Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)
- Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Directed Fluid Therapy Based on Stroke Volume Variations Improves Fluid Management in Endovascular Aortic Repair for Aortic Aneurysm Patients: a Randomized Trial
Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central venous pressure (CVP), guidance results in better clinical outcomes.
Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine level.
Methods: Adult patients undergoing endovascular aortic aneurysm repair (EVAR) will be randomized into 2 groups: SVV group managed by SVV guidance and CVP group managed by CVP guidance.
Outcome analyses: Compare serum lactate, creatinine as well as other postoperative complications between both groups.
Read the detailed description
Objective: To compare postoperative clinical outcome in adult patient undergoing EVAR.
Primary outcome: Postoperative serum lactate and creatinine.
Secondary outcome: Postoperative complications.
Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid management protocol. SVV group will be managed according to stroke volume variation (SVV) protocol, i.e., control SVV 10-13% and give fluid when SVV > 13%. CVP group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP < 8 mmHg.
Outcome analyses: Postoperative serum lactate and creatinine of both groups will be compared using unpaired Student-t test. Secondary outcomes will be compared using chi-square test.
- Conditions
- Postoperative Complications
- Being tested
- Fluid management protocol
- Keywords
- stroke volume variation, central venous pressure, serum lactate, serum creatinine
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid management protocolProcedure or surgery
SVV protocol: keep SVV 10-13% and give fluid when SVV > 13% CVP protocol: keep CVP 8-12 mmHG and give fluid when CVP < 8 mmHg
| Study group | Role | What they receive |
|---|---|---|
| SVV group | Experimental | Fluid management protocol Receives: Procedure: Fluid management protocol |
| CVP group | Active comparator | Fluid management protocol Receives: Procedure: Fluid management protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
lactate and creatinine level
serum lactate and creatinine level
Measured: at the end of surgery up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 May 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Model description
- Group SVV: fluid management guided by stroke volume variation (SVV) protocol Group CVP: fluid management guided by central venous pressure (CVP) protocol
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Thepakorn Sathitkarnmanee, Study chair, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218540
- Sponsor's protocol ID
- HE591258
- Status last verified
- Aug 2017
- First submitted
- 10 Jul 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22.
PubMed 23264068Kothandan H, Haw Chieh GL, Khan SA, Karthekeyan RB, Sharad SS. Anesthetic considerations for endovascular abdominal aortic aneurysm repair. Ann Card Anaesth. 2016 Jan-Mar;19(1):132-41. doi: 10.4103/0971-9784.173029.
PubMed 26750684Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. doi: 10.1016/j.bpa.2005.10.007.
PubMed 16850777
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directed Fluid Therapy Based on Stroke Volume Variations Improves Fluid Management in Endovascular Aortic Repair for Aortic Aneurysm Patients: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03218540
- Acronym / sponsor ID
- HE591258
- Conditions
- Postoperative Complications
- Keywords
- stroke volume variation, central venous pressure, serum lactate, serum creatinine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 14 Jul 2017 (actual)
- 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.
Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central venous pressure (CVP), guidance results in better clinical outcomes.
Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine level.
Methods: Adult patients undergoing endovascular aortic aneurysm repair (EVAR) will be randomized into 2 groups: SVV group managed by SVV guidance and CVP group managed by CVP guidance.
Outcome analyses: Compare serum lactate, creatinine as well as other postoperative complications between both groups.
Detailed description
Objective: To compare postoperative clinical outcome in adult patient undergoing EVAR.
Primary outcome: Postoperative serum lactate and creatinine.
Secondary outcome: Postoperative complications.
Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid management protocol. SVV group will be managed according to stroke volume variation (SVV) protocol, i.e., control SVV 10-13% and give fluid when SVV > 13%. CVP group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP < 8 mmHg.
Outcome analyses: Postoperative serum lactate and creatinine of both groups will be compared using unpaired Student-t test. Secondary outcomes will be compared using chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group SVV: fluid management guided by stroke volume variation (SVV) protocol Group CVP: fluid management guided by central venous pressure (CVP) protocol
| Arm | Type | Receives |
|---|---|---|
| SVV group | Experimental | Procedure: Fluid management protocolFluid management protocol |
| CVP group | Active comparator | Procedure: Fluid management protocolFluid management protocol |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40-80 years old
- Patient had aortic aneurysm both thoracic and abdominal types
- Scheduled for elective EVAR procedures
- New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
- Body mass index (BMI) 18-24 kg/m2
Key exclusion criteria (7 listed)
- Scheduled for emergency or redo surgery
- Received prior fluid therapy (>2,500 ml/day over the 48 h before the surgery)
- Presence of congenital heart disease, cardiomyopathy, rheumatic heart disease, or significant arrhythmia or cardiopulmonary dysfunction, or significant renal or liver diseases
- Preoperative use of vasoactive drugs (e.g. digoxin, nitroglycerine, nifedipine) for ≥3 months
- Difficulty (or contraindication to) placing a central venous catheter
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 |
|---|---|---|
| Fluid management protocolSVV protocol: keep SVV 10-13% and give fluid when SVV > 13% CVP protocol: keep CVP 8-12 mmHG and give fluid when CVP < 8 mmHg | Procedure or surgery | CVP group, SVV group |
Primary outcome
lactate and creatinine level
Time frame: at the end of surgery up to 48 hours
serum lactate and creatinine level
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 18 Aug 2017.
- Background: PubMed 23264068Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22.
- Results publication: PubMed 26750684Kothandan H, Haw Chieh GL, Khan SA, Karthekeyan RB, Sharad SS. Anesthetic considerations for endovascular abdominal aortic aneurysm repair. Ann Card Anaesth. 2016 Jan-Mar;19(1):132-41. doi: 10.4103/0971-9784.173029.
- Results publication: PubMed 16850777Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. doi: 10.1016/j.bpa.2005.10.007.
- Individual participant dataSharing planned: No
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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.
Thepakorn Sathitkarnmanee study chair
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid management protocol in people with Postoperative Complications, run by Khon Kaen University at 1 site in Thailand.
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 6 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 18 Aug 2017. 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 Thailand. 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?
lactate and creatinine level (time frame: at the end of surgery up to 48 hours). 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 NCT03218540, which also lists 3 linked publications.
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 18 Aug 2017.