Fluid Therapy
Conditions
Keywords
stroke volume variation, cardiac index, non-severe patients, gastrointestinal surgery
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.
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.
Interventions
DEVICEcardiac 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.
DEVICEStroke 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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Needed for Anal Exsufflation After Surgery | up to 8 weeks | record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Delivery（DO2） | during the surgery | 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. |
| Oxygen Consumption（VO2） | during the surgery | 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. |
| Oxygen Extraction Rate（ERO2） | during the surgery | 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. |
| Number of Days in Hospital | up to 10 weeks | The number of days from the admission to hospital until the discharge from hospital |
| the Incidence of Adverse Cardiovascular Events | during the surgery | including hypertension,hypotension,tachycardia,bradycardia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complication After Surgery | up to 8 weeks | From the end of surgery to the time of discharge from hospital.including ileus,abdominal infection,infection of incisional wound,pulmonary infection |
| The Volume of Colloid Infusion | during the surgery | Volume of colloid infusion in milliliter. |
| The Volume of Crystalloid Infusion | during the surgery | Volume of crystalloid infusion in milliliter. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Group Stroke Volume Variation | Total | Group Cardiac Index |
|---|---|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 8.3 | 40.3 years STANDARD_DEVIATION 8.1 | 40.9 years STANDARD_DEVIATION 7.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment China | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 10 Participants |
| Sex: Female, Male Male | 17 Participants | 32 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 2 / 25 | 1 / 25 |
| serious Total, serious adverse events | 5 / 25 | 1 / 25 |
Outcome results
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
Time frame: up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cardiac Index | Number of Days Needed for Anal Exsufflation After Surgery | 3.8 days | Standard Deviation 1.1 |
| Group Stroke Volume Variation | Number of Days Needed for Anal Exsufflation After Surgery | 2.7 days | Standard Deviation 1.2 |
Secondary
Number of Days in Hospital
The number of days from the admission to hospital until the discharge from hospital
Time frame: up to 10 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: during the surgery
Secondary
the Incidence of Adverse Cardiovascular Events
including hypertension,hypotension,tachycardia,bradycardia
Time frame: during the surgery
Other Pre-specified
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
Time frame: up to 8 weeks
Other Pre-specified
The Volume of Colloid Infusion
Volume of colloid infusion in milliliter.
Time frame: during the surgery
Other Pre-specified
The Volume of Crystalloid Infusion
Volume of crystalloid infusion in milliliter.
Time frame: during the surgery