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Trial registered on ANZCTR


Registration number
ACTRN12616000252415
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
23/02/2016
Date last updated
23/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Maternal cardiac effect of Hydroxyethyl Starch (HES) using LiDCO in cesarean section
Scientific title
Maternal cardiac effect of hydroxyethyl starch(HES) solution at different time using the LiDCO rapid system in cesarean section
Secondary ID [1] 288310 0
None
Universal Trial Number (UTN)
U1111-1178-4313
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy requiring caesarean section 297278 0
cardiac effect 297280 0
Condition category
Condition code
Anaesthesiology 297469 297469 0 0
Anaesthetics
Reproductive Health and Childbirth 297821 297821 0 0
Childbirth and postnatal care
Cardiovascular 297822 297822 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A rapid intravenous infusion of 6% hydroxyethyl starch solution HES 130/0.4 250ml was administered immediately before and the other after spinal anesthesia. Group P is the intervention group, who received HES 250ml immediately prior to spinal anaesthesia. Group A is the control group, who received HES 250ml immediately following spinal anaesthesia. Dose administered and logged by anaesthetist.
Intervention code [1] 293604 0
Treatment: Drugs
Comparator / control treatment
Sixty patients undergoing selective cesarean section, aged 20 to 30 years old, were randomly divided into group P and group A.Group P is the intervention group, who received HES 250ml immediately prior to spinal anaesthesia. Group A is the control group, who received HES 250ml immediately following spinal anaesthesia.
Control group
Active

Outcomes
Primary outcome [1] 297040 0
Cardiac output (CO) assessed using LiDCO rapid (arterial pressure waveform analysis).
Timepoint [1] 297040 0
Baseline (T0), immediately after spinal anesthesia (T1), skin incision (T2), neonates delivery (T3), the placenta delivery (T4), immediately after injection of oxytocin on uterine muscle wall (T5), end of operation (T6)
Primary outcome [2] 297346 0
Mean arterial pressure (MAP) assessed using LiDCO rapid (arterial pressure waveform analysis).
Timepoint [2] 297346 0
Baseline (T0), immediately after spinal anesthesia (T1), skin incision (T2), neonates delivery (T3), the placenta delivery (T4), immediately after injection of oxytocin on uterine muscle wall (T5), end of operation (T6)
Primary outcome [3] 297347 0
Stroke volume (SV) assessed using LiDCO rapid (arterial pressure waveform analysis).
Timepoint [3] 297347 0
Baseline (T0), immediately after spinal anesthesia (T1), skin incision (T2), neonates delivery (T3), the placenta delivery (T4), immediately after injection of oxytocin on uterine muscle wall (T5), end of operation (T6)
Secondary outcome [1] 319903 0
nausea, assessed using 5-point Likert Scale
Timepoint [1] 319903 0
Every 10 minutes following spinal anaesthesia for 2 hours.
Secondary outcome [2] 320772 0
headache, assessed using VAS pain score
Timepoint [2] 320772 0
Every 10 minutes following spinal anaesthesia for 2 hours.

Eligibility
Key inclusion criteria
(1) primiparas who underwent elective cesarean section (2)age of 20–30 years, (3) body weight of 60–90 kg, (4) ASA class 1–2, (5) no contraindications to spinal anesthesia.
Minimum age
20 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) multiple pregnancy, (2) height less than 150 cm, (3) placenta previa, (4) complications including diabetes mellitus, hypertensive diseases in pregnancy, etc. (5) contraindication to central neural blockade (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/05/2014
Date of last participant enrolment
Anticipated
Actual
30/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7515 0
China
State/province [1] 7515 0
Liaoning

Funding & Sponsors
Funding source category [1] 292685 0
Hospital
Name [1] 292685 0
Department of anesthesiology of Shengjing Hospital of China Medical University
Country [1] 292685 0
China
Primary sponsor type
Individual
Name
Guang Han
Address
NO.36, Sanhao Street, Herping District, Shenyang, China,110003
Department of Anesthesiology, Shengjing Hospital, China Medical University,
Country
China
Secondary sponsor category [1] 291408 0
Individual
Name [1] 291408 0
Ping Zhao
Address [1] 291408 0
NO.36, Sanhao Street, Herping District, Shenyang, China,110003
Department of Anesthesiology, Shengjing Hospital, China Medical University
Country [1] 291408 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294158 0
the ethics committee of Shengjing Hospital
Ethics committee address [1] 294158 0
NO.36, Sanhao Street, Herping District, Shenyang, China,110003
Ethics committee country [1] 294158 0
China
Date submitted for ethics approval [1] 294158 0
Approval date [1] 294158 0
04/05/2014
Ethics approval number [1] 294158 0
2014PS15K

Summary
Brief summary
This study evaluated the maternal cardiac effect of hydroxyethyl starch(HES) solution when administrated preload or afterload in cesarean section under spinal anesthesia through minimally invasive arterial monitoring system LiDCO rapid. Sixty patients undergoing selective cesarean section, aged 20 to 30 years old, were randomly divided into pre-loading HES group (group P) and after-loading HES group (group A). Except a routine BP, ECG, SpO2 monitoring, every patient was connected to the LiDCO rapid (arterial pressure waveform analysis) to monitor CO. After establishing venous access, group P and group A were respectively administered a rapid intravenous infusion of 6% hydroxyethyl starch solution HES 130/0.4 250ml before or after spinal anesthesia within 5 min. The LiDCO monitoring system could record the indexes of heart rate (HR), cardiac output (CO), mean arterial pressure (MAP) and left ventricle stroke volume (SV) continuously. We compared these values at some time points and incidence of hypotension.
Results Group P was significantly higher than group A in MAP,CO and SV at these time points including T1, T2 and T3 after spinal anesthesia (P<0.05). But it had not statistical difference in MAP, CO and SV at other points (P>0.05). There were no significant differences in HR between the two groups at all points(P>0.05). Phenylephrine requirements in group P were lower than group A(P<0.05).
Conclusions Administering HES before spinal anesthesia could increase the CO, MAP, SV and prevent hypotension more effectively. So pre-loading fluid therapy might have more stable cardiac effect in cesarean section with spinal anesthesia.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 703 703 0 0
/AnzctrAttachments/369915-Certification.doc
Attachments [2] 704 704 0 0
/AnzctrAttachments/369915-Fig 1.pdf

Contacts
Principal investigator
Name 62718 0
Prof Ping Zhao
Address 62718 0
NO.36, Sanhao Street, Herping District, Shenyang, China,110003
Department of Anesthesiology, Shengjing Hospital, China Medical University
Country 62718 0
China
Phone 62718 0
+86-024-25672468
Fax 62718 0
Email 62718 0
[email protected]
Contact person for public queries
Name 62719 0
Mrs Guang Han
Address 62719 0
NO.36, Sanhao Street, Herping District, Shenyang, China,110003
Department of Anesthesiology, Shengjing Hospital, China Medical University
Country 62719 0
China
Phone 62719 0
+86-18940258839
Fax 62719 0
Email 62719 0
[email protected]
Contact person for scientific queries
Name 62720 0
Mrs Guang Han
Address 62720 0
NO.36, Sanhao Street, Herping District, Shenyang, China,110003
Department of Anesthesiology, Shengjing Hospital, China Medical University
Country 62720 0
China
Phone 62720 0
+86-18940258839
Fax 62720 0
Email 62720 0
[email protected]

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