The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients
NCT ID: NCT02841046
Last Updated: 2020-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-07-27
2019-06-25
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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group cardiac index
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 .
cardiac index
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.
group Stroke Volume Variation
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 .
Stroke Volume Variation
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.
Interventions
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cardiac index
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 Variation
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.
Eligibility Criteria
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Inclusion Criteria
* Cardiac function classification by NYHA of grade I
* without high risk factors according to the revised Lee cardiac risk index:
1. High-risk type of surgery
2. Ischemic heart disease
3. History of congestive heart failure
4. History of cerebrovascular disease
5. Insulin therapy for diabetes
6. Preoperative serum creatinine \> 2.0 mg/dl
* undergoing gastrointestinal tumor surgery
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Lin Yang
Attending Physician
Principal Investigators
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Shu HaiHua, doctor
Role: STUDY_CHAIR
First Affiliated Hospital, Sun Yat-Sen University
References
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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.
Futier 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.
Cannesson 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.
Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. doi: 10.4103/0971-9784.38455.
Cannesson 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.
Hofer 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.
Mayer 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.
Vasdev 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.
Samra 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.
Berkenstadt 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.
Michard 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.
Mayer 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.
Lang 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.
Lequeux 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.
Lee 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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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[2014]No.60
Identifier Type: -
Identifier Source: org_study_id
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