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
Phase: NA
Conditions: Fluid Therapy
Sponsor: First Affiliated Hospital, Sun Yat-Sen University

 
 
 
 
 
 
 
The study of stroke volume variation 
combined with cardiac index in guiding volume 
therapy 
in 
non-severe 
patients 
undergoing 
intestinal neoplasm surgery  
 
NCT02841046 
2019-8-10 
 
 
 
 
 
 
 
 

The study of stroke volume variation combined with cardiac 
index in guiding volume therapy in non-severe patients 
undergoing intestinal neoplasm surgery  
NCT02841046 
    【Abstract】Objective To observe the application of goal-directed therapy 
(GDT) with the combination of stroke volume variation(SVV) and cardiac index(CI) 
as the primary judgment in non-severe patients undergoing intestinal neoplasm 
surgery. Methods 50 patients (ASA Ⅰ-Ⅱ,26-55 years old) scheduled for 
intestinal neoplasm surgery were divided randomly: group C using CI as the 
primary judgment for GDT and group S with the combination of SVV and CI. 
Patients in group C received a therapy with the goal of CI was no less than 
2.5L•min
-1•m
-2 while in group S was both SVV less than 12% and CI no less than 
2.5L•min
-1•m
-2. HR, MAP, CVP, CI, SVV were recorded 15 minutes after the 
induction of anesthesia(T1), making surgical incision(T2), performing intestinal 
anastomosis(T3) 
and 
closing 
the 
abdominal 
incision(T4). 
Oxygen 
delivery(DO2),oxygen consumption(VO2),O2 extraction rate (ERO2)and plasma 
Lactic acid(Lac) were monitored at T1 and T4. The volume of fluid, the incidence 
of adverse cardiovascular events, the exhaust time, hospital stay and 
complications were recorded. Results in group S, the amount of colloidal fluid 
increased and crystalline fluid decreased, the incidence of hypotension was lower 
than group C. DO2, VO2 were increased and Lac decreased at T4 in group S. The 
exhaust time and hospital stay were reduced in group S. (P <0.05) Conclusions 

GDT with the combination of SVV and CI as the primary judgment maintained a 
more stable hemodynamic and better tissue perfusion, which helps to improve 
the prognosis of patients. This protocol was more suitable for the non-severe 
patients. 
【Key words】stroke volume variation; cardiac index; non-severe; volume 
therapy 
 
Statistical Analysis methods : Spss19.0 statistical software was used to analyze 
the data（x ± s) means that independent sample t-test is used for normal 
distribution, independent sample rank sum test is used for non normal distribution, 
ANOVA is used for comparison of different time points of hemodynamics and 
oxygen metabolism indexes, paired t-test is used for comparison of two time 
points, chi square test is used for counting data, and P < 0.05 is statistically 
significant. 
 
 
 
 
 
 
 
 

Informed Consent Form 
 
Study Name: The study of stroke volume variation combined with cardiac index 
in guiding volume therapy in non severe patients undergoing intestinal neoplasm 
surgery 
 
Project Leader: Yang Lin                          Tel: 87755766 to 8273 
 
1. Research purpose 
To observe the application of goal-directed therapy (GDT) with the 
combination of stroke volume variation(SVV) and cardiac index(CI) as the primary 
judgment in non-severe patients undergoing intestinal neoplasm surgery. To 
compare the difference of hospitalization time, postoperative complication rate 
and other indexes to explore a better rehydration scheme for non severe patients. 
 
2. Research process 
This study is to be conducted from July 2016 to July 2018. It is a prospective 
randomized controlled parallel study. 50 patients scheduled for intestinal 
neoplasm surgery were divided randomly into two groups, 25 patients in each 
group. According to different target directed rehydration schemes, the two 
groups adjusted rehydration speed and guided the application of vasoactive 
drugs by monitoring the real-time values of SVV, CI and SVI. 

During the large-scale gastrointestinal operation, the routine deep vein 
puncture and artery puncture will not increase the additional trauma during the 
whole process of experiment, evaluation and follow-up, and no additional blood 
or other tissue samples need to be taken, and no additional laboratory 
examination is required. However, Vigileo technology is used in all patients, and 
the consumables of this monitoring project need to be paid by you. 
 
3. Possible risks 
Goal-directed therapy has been proved to be feasible by a large number of 
studies, and it has been shown that this method can shorten the hospitalization 
time of high-risk surgical patients and reduce the incidence of postoperative 
complications, and no obvious complications have been found so far. However, 
in order to ensure your safety, we will strictly control the inclusion and exclusion 
criteria of the subjects, closely monitor, actively follow up, and timely find 
complications. If there are complications, we will actively treat the symptoms and 
bear the corresponding treatment costs. 
 
4. Subject benefit 
   1) More accurate intraoperative capacity management; 2) Beneficial to shorten 
the length of stay; 3) Beneficial to reduce the incidence of postoperative adverse 
reactions. 
 

5. Confidentiality of research records 
We will keep your identity records and personal data completely confidential, 
and the medical records related to your identification will also be kept confidential. 
Your name and personal information will not appear in research reports and 
publications. 
 
6. Rights of subjects 
   Participation in this study is voluntary. You can refuse to participate in the 
study or withdraw from the study at any time at any stage of the study without 
any discrimination or retaliation. Your medical treatment and rights and interests 
will be affected in any way. 
 
7. Subject statement 
   I have read the research contents indicated in this informed consent in detail, 
and my doctor has given me a detailed description of the research scheme. I fully 
understand the purpose, quality, method, rights and risks of participating in this 
study. I learned that my personal data is confidential and my right to privacy is 
protected. 
I volunteered to participate in this study, and agreed to cooperate with 
doctors in accordance with the research plan and informed consent to 
complete this study. 
 

Subject signature             Date      /      /     TEL               
Doctor signature             Date      /      /     TEL