Trial Outcomes & Findings for The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients (NCT NCT02841046)

Results Overview

record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

up to 8 weeks

Results posted on

2020-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Cardiac Index n=25 Participants 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.	Group Stroke Volume Variation n=25 Participants 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 n=50 Participants Total of all reporting groups
Age, Continuous	40.9 years STANDARD_DEVIATION 7.9 • n=25 Participants	39.7 years STANDARD_DEVIATION 8.3 • n=25 Participants	40.3 years STANDARD_DEVIATION 8.1 • n=50 Participants
Sex: Female, Male Female	10 Participants n=25 Participants	8 Participants n=25 Participants	18 Participants n=50 Participants
Sex: Female, Male Male	15 Participants n=25 Participants	17 Participants n=25 Participants	32 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	25 participants n=25 Participants	25 participants n=25 Participants	50 participants n=50 Participants

PRIMARY outcome

Timeframe: up to 8 weeks

record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery

Outcome measures

Outcome measures
Measure	Group Cardiac Index n=25 Participants 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.	Group Stroke Volume Variation n=25 Participants 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.
Number of Days Needed for Anal Exsufflation After Surgery	3.8 days Standard Deviation 1.1	2.7 days Standard Deviation 1.2

SECONDARY outcome

Timeframe: during the surgery

including hypertension,hypotension,tachycardia,bradycardia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 10 weeks

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: during the surgery

Volume of crystalloid infusion in milliliter.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: during the surgery

Volume of colloid infusion in milliliter.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Group Cardiac Index

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Group Stroke Volume Variation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group Cardiac Index n=25 participants at risk 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.	Group Stroke Volume Variation n=25 participants at risk 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.
Gastrointestinal disorders abdominal infection	16.0% 4/25 • 2 months	4.0% 1/25 • 2 months
Gastrointestinal disorders ileus	12.0% 3/25 • 2 months	0.00% 0/25 • 2 months

Other adverse events

Other adverse events
Measure	Group Cardiac Index n=25 participants at risk 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.	Group Stroke Volume Variation n=25 participants at risk 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.
Infections and infestations infection of incisional wound	8.0% 2/25 • 2 months	4.0% 1/25 • 2 months

Additional Information

Dr. Yang Lin

Guangzhou Panyu central Hospital

Phone: +8615915721012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place