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

Fluid Therapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841046
• Other study ID #: [2014]No.60
• Status: Completed
• Phase: N/A
• Start date: July 27, 2016
• Est. completion date: June 25, 2019

Study information

• Verified date: February 2020
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 25, 2019
• Est. primary completion date: May 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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:

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 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

Related Conditions & MeSH terms

• Fluid Therapy
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

References & Publications (15)

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. — View Citation

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;2 — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Arc — View Citation

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. — View Citation

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. Retraction in: Miller DR. Can J Anaesth. 2011 Se — View Citation

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 su — View Citation

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: 1 — View Citation

Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. Review. — View Citation

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/aep13 — View Citation

Mayer J, Boldt J, Mengistu AM, Röhm 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) — View Citation

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. — View Citation

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. — View Citation

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 Comp — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Volume of Crystalloid Infusion	Volume of crystalloid infusion in milliliter.	during the surgery
Other	The Volume of Colloid Infusion	Volume of colloid infusion in milliliter.	during the surgery
Other	Complication After Surgery	From the end of surgery to the time of discharge from hospital.including ileus,abdominal infection,infection of incisional wound,pulmonary infection	up to 8 weeks
Primary	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	the Incidence of Adverse Cardiovascular Events	including hypertension,hypotension,tachycardia,bradycardia	during the surgery
Secondary	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.	during the surgery
Secondary	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.	during the surgery
Secondary	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.	during the surgery
Secondary	Number of Days in Hospital	The number of days from the admission to hospital until the discharge from hospital	up to 10 weeks