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

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02841046
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Actual Duration (Months): 34.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fluid Therapy	Device: cardiac index; Device: Stroke Volume Variation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 27, 2016
• Actual Primary Completion Date: May 18, 2019
• Actual Study Completion Date: Jun 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 .	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.
Experimental: 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 .	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. the Incidence of Adverse Cardiovascular Events [during the surgery]

   including hypertension,hypotension,tachycardia,bradycardia

2. 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.

3. 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.

4. 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.

5. Number of Days in Hospital [up to 10 weeks]

   The number of days from the admission to hospital until the discharge from hospital

Other Outcome Measures

1. The Volume of Crystalloid Infusion [during the surgery]

   Volume of crystalloid infusion in milliliter.

2. The Volume of Colloid Infusion [during the surgery]

   Volume of colloid infusion in milliliter.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• First Affiliated Hospital, Sun Yat-Sen University

Investigators

• Study Chair: Shu HaiHua, doctor, First Affiliated Hospital, Sun Yat-Sen University

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Aug 10, 2019

More Information

Publications

None provided.

• Responsible Party: Lin Yang, Attending Physician, First Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT02841046
• Other Study ID Numbers: [2014]No.60
• First Posted: Jul 21, 2016
• Last Update Posted: Mar 3, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Lin Yang, Attending Physician, First Affiliated Hospital, Sun Yat-Sen University: stroke volume variation; cardiac index; non-severe patients; gastrointestinal surgery
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Group Cardiac Index	Group Stroke Volume Variation
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group Cardiac Index	Group Stroke Volume Variation	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	25	25	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.9 (7.9)	39.7 (8.3)	40.3 (8.1)
Sex: Female, Male (Count of Participants)
Female	10 40%	8 32%	18 36%
Male	15 60%	17 68%	32 64%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
China	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Number of Days Needed for Anal Exsufflation After Surgery
Description	record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery
Time Frame	up to 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Cardiac Index	Group Stroke Volume Variation
Arm/Group Description	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.	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.
Measure Participants	25	25
Mean (Standard Deviation) [days]	3.8 (1.1)	2.7 (1.2)

2. Secondary Outcome

Title	the Incidence of Adverse Cardiovascular Events
Description	including hypertension,hypotension,tachycardia,bradycardia
Time Frame	during the surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Oxygen Delivery（DO2）
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Oxygen Consumption（VO2）
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Oxygen Extraction Rate（ERO2）
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Number of Days in Hospital
Description	The number of days from the admission to hospital until the discharge from hospital
Time Frame	up to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	The Volume of Crystalloid Infusion
Description	Volume of crystalloid infusion in milliliter.
Time Frame	during the surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	The Volume of Colloid Infusion
Description	Volume of colloid infusion in milliliter.
Time Frame	during the surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Complication After Surgery
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	2 months
Arm/Group Title	Group Cardiac Index		Group Stroke Volume Variation
Arm/Group Description	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.		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.
All Cause Mortality
	Group Cardiac Index		Group Stroke Volume Variation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Group Cardiac Index		Group Stroke Volume Variation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/25 (20%)		1/25 (4%)
Gastrointestinal disorders
abdominal infection	4/25 (16%)		1/25 (4%)
ileus	3/25 (12%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Group Cardiac Index		Group Stroke Volume Variation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/25 (8%)		1/25 (4%)
Infections and infestations
infection of incisional wound	2/25 (8%)		1/25 (4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.