The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients

NCT02841046 | Completed Results DMC

• 1 other identifier: [2014]No.60
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Fluid Therapy

Keywords

stroke volume variation; cardiac index; non-severe patients; gastrointestinal surgery

Outcome Measures

Primary Outcomes (1)

• 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

  up to 8 weeks

Secondary Outcomes (5)

• the Incidence of Adverse Cardiovascular Events

  during the surgery

• Oxygen Delivery（DO2）

  during the surgery

• Oxygen Consumption（VO2）

  during the surgery

• Oxygen Extraction Rate（ERO2）

  during the surgery

• Number of Days in Hospital

  up to 10 weeks

Other Outcomes (3)

• The Volume of Crystalloid Infusion

  during the surgery

• The Volume of Colloid Infusion

  during the surgery

• Complication After Surgery

  up to 8 weeks

Study Arms (2)

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 .

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 .

Device: Stroke Volume Variation

Interventions

cardiac index DEVICE

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 cardiac index

Stroke Volume Variation DEVICE

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.

group Stroke Volume Variation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• History of cerebrovascular disease
• Insulin therapy for diabetes
• Preoperative serum creatinine \> 2.0 mg/dl
• undergoing gastrointestinal tumor surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (15)

• 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.

  PMID: 21540811 RESULT

• 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.

  PMID: 21173294 RESULT

• 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.

  PMID: 20022261 RESULT

• Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. doi: 10.4103/0971-9784.38455.

  PMID: 18182765 RESULT

• 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.

  PMID: 17666154 RESULT

• 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.

  PMID: 18570641 RESULT

• 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.

  PMID: 19482857 RESULT

• 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.

  PMID: 22350311 RESULT

• 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.

  PMID: 21636945 RESULT

• 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.

  PMID: 11273937 RESULT

• 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.

  PMID: 14605066 RESULT

• 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.

  PMID: 20156348 RESULT

• 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.

  PMID: 14656778 RESULT

• 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.

  PMID: 19935073 RESULT

• 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.

  PMID: 10477528 RESULT

Results Point of Contact

• Title: Dr. Yang Lin
• Organization: Guangzhou Panyu central Hospital

salinyangyl@163.com

+8615915721012

Study Officials

• Shu HaiHua, doctor

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 21, 2016
• Study Start: July 27, 2016
• Primary Completion: May 18, 2019
• Study Completion: June 25, 2019
• Last Updated: March 3, 2020
• Results First Posted: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL