Fluid TherapyNCT02841046
The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients
A study testing cardiac index and Stroke Volume Variation in people with Fluid Therapy, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fluid Therapy
- What is being tested?
- cardiac index and Stroke Volume Variation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 27 Jul 2016to 25 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status of grade I-II
- Cardiac function classification by NYHA of grade I
- without high risk factors according to the revised Lee cardiac risk index:
- High-risk type of surgery
- Ischemic heart disease
- History of congestive heart failure
Show all 10Show fewer
- History of cerebrovascular disease
- Insulin therapy for diabetes
- Preoperative serum creatinine > 2.0 mg/dl
- undergoing gastrointestinal tumor surgery
Who cannot join
- Patients under 18 years or above 55 years
- patients with severe aortic regurgitation
- patients with permanent cardiac arrhythmias
- patients with intra-aortic balloon pump
- patients with severe pulmonary disease
- patients with hepatic or renal dysfunction
- patients undergoing emergency surgery
About this study
Official title: The Application of Goal-directed Therapy With the Combination of Stroke Volume Variation and Cardiac Index as the Primary Judgment in Non-severe Patients Underwent Gastrointestinal Tumor Surgery
To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment.
Read the detailed description
To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor.
Methods: Fifty patients (ASA Ⅰ-Ⅱ, 18-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment. Patients in group C received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 while SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 in group S. Indexes including MAP、HR、CVP、CI、SVV were recorded at the moment after anaesthetized (T1), when skin was incised (T2), when the intestina was anastomosed (T3) and after the abdomen was closed (T4). SaO2、ScvO2 and plasma lactic were determined at T1 and T4 and DO2,VO2 and ERO2 during the surgery were calculated .The volume of fluid, vasoactive drugs use, the incidence of adverse cardiovascular events, the convalescence of intestinal peristalsis, hospital stay and postoperative complications were recorded.
- Conditions
- Fluid Therapy
- Being tested
- cardiac index, Stroke Volume Variation
- Keywords
- stroke volume variation, cardiac index, non-severe patients, gastrointestinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac indexDevice
group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.
Stroke Volume VariationDevice
group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.
| Study group | Role | What they receive |
|---|---|---|
| group cardiac index | Other | the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index（CI） as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 . Receives: Device: cardiac index |
| group Stroke Volume Variation | Experimental | the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation（SVV）and cardiac index（CI）as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 . Receives: Device: Stroke Volume Variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Needed for Anal Exsufflation After Surgery
record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery
Measured: up to 8 weeks
Secondary outcomes (5)
the Incidence of Adverse Cardiovascular Events
including hypertension,hypotension,tachycardia,bradycardia
Measured: during the surgery
Oxygen Delivery（DO2）
oxygen delivery（DO2) in ml•min-1•m-2.Record the data of DO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
Measured: during the surgery
Oxygen Consumption（VO2）
oxygen delivery（VO2) in ml•min-1•m-2.Record the data of VO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
Measured: during the surgery
Oxygen Extraction Rate（ERO2）
oxygen extraction rate(ERO2) in percentage.Record the data of ERO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
Measured: during the surgery
Number of Days in Hospital
The number of days from the admission to hospital until the discharge from hospital
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start27 Jul 2016
- Primary completion18 May 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Shu HaiHua, doctor, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841046
- Sponsor's protocol ID
- [2014]No.60
- Status last verified
- Feb 2020
- First submitted
- 8 Jul 2016
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: It should be discuss.
Publications
Della Rocca G, Pompei L. Goal-directed therapy in anesthesia: any clinical impact or just a fashion? Minerva Anestesiol. 2011 May;77(5):545-53. Epub 2011 Mar 1.
PubMed 21540811Futier E, Constantin JM, Petit A, Chanques G, Kwiatkowski F, Flamein R, Slim K, Sapin V, Jaber S, Bazin JE. Conservative vs restrictive individualized goal-directed fluid replacement strategy in major abdominal surgery: A prospective randomized trial. Arch Surg. 2010 Dec;145(12):1193-200. doi: 10.1001/archsurg.2010.275.
PubMed 21173294Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97. doi: 10.1053/j.jvca.2009.10.008. No abstract available.
PubMed 20022261Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. doi: 10.4103/0971-9784.38455.
PubMed 18182765Cannesson M, Attof Y, Rosamel P, Joseph P, Bastien O, Lehot JJ. Comparison of FloTrac cardiac output monitoring system in patients undergoing coronary artery bypass grafting with pulmonary artery cardiac output measurements. Eur J Anaesthesiol. 2007 Oct;24(10):832-9. doi: 10.1017/S0265021507001056. Epub 2007 Aug 1.
PubMed 17666154Hofer CK, Senn A, Weibel L, Zollinger A. Assessment of stroke volume variation for prediction of fluid responsiveness using the modified FloTrac and PiCCOplus system. Crit Care. 2008;12(3):R82. doi: 10.1186/cc6933. Epub 2008 Jun 20.
PubMed 18570641Mayer J, Boldt J, Beschmann R, Stephan A, Suttner S. Uncalibrated arterial pressure waveform analysis for less-invasive cardiac output determination in obese patients undergoing cardiac surgery. Br J Anaesth. 2009 Aug;103(2):185-90. doi: 10.1093/bja/aep133. Epub 2009 May 29.
PubMed 19482857Vasdev S, Chauhan S, Choudhury M, Hote MP, Malik M, Kiran U. Arterial pressure waveform derived cardiac output FloTrac/Vigileo system (third generation software): comparison of two monitoring sites with the thermodilution cardiac output. J Clin Monit Comput. 2012 Apr;26(2):115-20. doi: 10.1007/s10877-012-9341-5. Epub 2012 Feb 17.
PubMed 22350311Samra T, Arya VK. Comparison of cardiac output estimation by FloTrac/Vigileo TM and intermittent pulmonary artery thermodilution in patient with Takayasu arteritis. Ann Card Anaesth. 2011 May-Aug;14(2):163-4. doi: 10.4103/0971-9784.81579. No abstract available.
PubMed 21636945Berkenstadt H, Margalit N, Hadani M, Friedman Z, Segal E, Villa Y, Perel A. Stroke volume variation as a predictor of fluid responsiveness in patients undergoing brain surgery. Anesth Analg. 2001 Apr;92(4):984-9. doi: 10.1097/00000539-200104000-00034.
PubMed 11273937Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.
PubMed 14605066Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.
PubMed 20156348Lang K, Suttner S, Boldt J, Kumle B, Nagel D. Volume replacement with HES 130/0.4 may reduce the inflammatory response in patients undergoing major abdominal surgery. Can J Anaesth. 2003 Dec;50(10):1009-16. doi: 10.1007/BF03018364.
PubMed 14656778Lequeux PY, Bouckaert Y, Sekkat H, Van der Linden P, Stefanidis C, Huynh CH, Bejjani G, Bredas P. Continuous mixed venous and central venous oxygen saturation in cardiac surgery with cardiopulmonary bypass. Eur J Anaesthesiol. 2010 Mar;27(3):295-9. doi: 10.1097/EJA.0b013e3283315ad0.
PubMed 19935073Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.
PubMed 10477528
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Goal-directed Therapy With the Combination of Stroke Volume Variation and Cardiac Index as the Primary Judgment in Non-severe Patients Underwent Gastrointestinal Tumor Surgery
- ClinicalTrials.gov ID
- NCT02841046
- Acronym / sponsor ID
- [2014]No.60
- Conditions
- Fluid Therapy
- Keywords
- stroke volume variation, cardiac index, non-severe patients, gastrointestinal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 18 May 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Posted 3 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment.
Detailed description
To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor.
Methods: Fifty patients (ASA Ⅰ-Ⅱ, 18-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment. Patients in group C received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 while SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 in group S. Indexes including MAP、HR、CVP、CI、SVV were recorded at the moment after anaesthetized (T1), when skin was incised (T2), when the intestina was anastomosed (T3) and after the abdomen was closed (T4). SaO2、ScvO2 and plasma lactic were determined at T1 and T4 and DO2,VO2 and ERO2 during the surgery were calculated .The volume of fluid, vasoactive drugs use, the incidence of adverse cardiovascular events, the convalescence of intestinal peristalsis, hospital stay and postoperative complications were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group cardiac index | Other | Device: cardiac indexthe treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index（CI） as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 . |
| group Stroke Volume Variation | Experimental | Device: Stroke Volume Variationthe treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation（SVV）and cardiac index（CI）as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 . |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- American Society of Anesthesiologists (ASA) physical status of grade I-II
- Cardiac function classification by NYHA of grade I
- without high risk factors according to the revised Lee cardiac risk index:
- undergoing gastrointestinal tumor surgery
Key exclusion criteria (7 listed)
- Patients under 18 years or above 55 years
- patients with severe aortic regurgitation
- patients with permanent cardiac arrhythmias
- patients with intra-aortic balloon pump
- patients with severe pulmonary disease
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 |
|---|---|---|
| cardiac indexgroup cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment. | Device | group cardiac index |
| Stroke Volume Variationgroup cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment. | Device | group Stroke Volume Variation |
Primary outcome
Number of Days Needed for Anal Exsufflation After Surgery
Time frame: up to 8 weeks
record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery
5 secondary outcomes
the Incidence of Adverse Cardiovascular Events
Time frame: during the surgery
Oxygen Delivery（DO2）
Time frame: during the surgery
Oxygen Consumption（VO2）
Time frame: during the surgery
Oxygen Extraction Rate（ERO2）
Time frame: during the surgery
Number of Days in Hospital
Time frame: up to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21540811Della Rocca G, Pompei L. Goal-directed therapy in anesthesia: any clinical impact or just a fashion? Minerva Anestesiol. 2011 May;77(5):545-53. Epub 2011 Mar 1.
- Results publication: PubMed 21173294Futier E, Constantin JM, Petit A, Chanques G, Kwiatkowski F, Flamein R, Slim K, Sapin V, Jaber S, Bazin JE. Conservative vs restrictive individualized goal-directed fluid replacement strategy in major abdominal surgery: A prospective randomized trial. Arch Surg. 2010 Dec;145(12):1193-200. doi: 10.1001/archsurg.2010.275.
- Results publication: PubMed 20022261Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97. doi: 10.1053/j.jvca.2009.10.008. No abstract available.
- Results publication: PubMed 18182765Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. doi: 10.4103/0971-9784.38455.
- Results publication: PubMed 17666154Cannesson M, Attof Y, Rosamel P, Joseph P, Bastien O, Lehot JJ. Comparison of FloTrac cardiac output monitoring system in patients undergoing coronary artery bypass grafting with pulmonary artery cardiac output measurements. Eur J Anaesthesiol. 2007 Oct;24(10):832-9. doi: 10.1017/S0265021507001056. Epub 2007 Aug 1.
- Results publication: PubMed 18570641Hofer CK, Senn A, Weibel L, Zollinger A. Assessment of stroke volume variation for prediction of fluid responsiveness using the modified FloTrac and PiCCOplus system. Crit Care. 2008;12(3):R82. doi: 10.1186/cc6933. Epub 2008 Jun 20.
- Results publication: PubMed 19482857Mayer J, Boldt J, Beschmann R, Stephan A, Suttner S. Uncalibrated arterial pressure waveform analysis for less-invasive cardiac output determination in obese patients undergoing cardiac surgery. Br J Anaesth. 2009 Aug;103(2):185-90. doi: 10.1093/bja/aep133. Epub 2009 May 29.
- Results publication: PubMed 22350311Vasdev S, Chauhan S, Choudhury M, Hote MP, Malik M, Kiran U. Arterial pressure waveform derived cardiac output FloTrac/Vigileo system (third generation software): comparison of two monitoring sites with the thermodilution cardiac output. J Clin Monit Comput. 2012 Apr;26(2):115-20. doi: 10.1007/s10877-012-9341-5. Epub 2012 Feb 17.
- Results publication: PubMed 21636945Samra T, Arya VK. Comparison of cardiac output estimation by FloTrac/Vigileo TM and intermittent pulmonary artery thermodilution in patient with Takayasu arteritis. Ann Card Anaesth. 2011 May-Aug;14(2):163-4. doi: 10.4103/0971-9784.81579. No abstract available.
- Results publication: PubMed 11273937Berkenstadt H, Margalit N, Hadani M, Friedman Z, Segal E, Villa Y, Perel A. Stroke volume variation as a predictor of fluid responsiveness in patients undergoing brain surgery. Anesth Analg. 2001 Apr;92(4):984-9. doi: 10.1097/00000539-200104000-00034.
- Results publication: PubMed 14605066Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.
- Results publication: PubMed 20156348Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.
- Individual participant dataSharing planned: Yes. It should be discuss.
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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.
Shu HaiHua, doctor study chair
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing cardiac index and Stroke Volume Variation in people with Fluid Therapy, run by First Affiliated Hospital, Sun Yat-Sen University.
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 10 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 3 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days Needed for Anal Exsufflation After Surgery (time frame: up to 8 weeks). 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 NCT02841046, which also lists 15 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 3 Mar 2020.