Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201604001597634 Date of Approval: 21/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of goal directed fluid, inotrope and vasopressor therapy in preeclamptic patients undergoing caesarean section delivery under spinal anaest
Official scientific title The effect of goal directed fluid, inotrope and vasopressor therapy in preeclamptic patients undergoing caesarean section delivery under spinal anaesthesia with the use of a non-invasive finger cuff cardiac output monitor
Brief summary describing the background and objectives of the trial The haemodynamic response to spinal anaesthesia in patients with preeclampsia is poorly understood and often characterised by significant haemodynamic fluctuations which may compromise utero-placental blood flow and so neonatal outcomes. Blood pressure is routinely used as a surrogate marker of cardiac output. Numerous studies have demonstrated a poor correlation between blood pressure and utero-placental blood flow in preeclamptic patients. Furthermore, several studies indicate that the changes in cardiac output induced by spinal anaesthesia are more closely matched to changes in utero-placental blood flow. It may therefore be advantageous to measure cardiac output directly. The availability of new, non-invasive technologies, such as the ClearSight (Edwards LifeSciences, Irvine, California, United States of America), is likely to make perioperative monitoring of cardiac output more accessible, readily applicable and a viable option for the intraoperative management of all preeclamptic patients presenting for caesarean section delivery. The ClearSight has been validated in a number of clinical settings and is approved by the manufacturer for use in obstetric patients. Currently, however, there is a paucity of literature regarding their role in the management of patients undergoing caesarean section delivery. The primary outcome of the study is to document the effect of goal directed therapy using a non-invasive finger cuff cardiac output monitor on umbilical cord lactate in patients with preeclampsia, undergoing caesarean section delivery under spinal anaesthesia. Secondary outcomes include the change in umbilical cord pH, base excess, cortisol levels and neonatal APGAR scores as well as the change in maternal haemodynamic variables including cardiac output, cardiac index, systemic vascular resistance, systemic vascular resistance index and stroke volume variation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/05/2016
Actual trial start date
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised The patient will be randomised to one of two groups by means of a sealed envelope. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard monitoring group Standard anaesthetic monitoring including non-invasive blood pressure monitoring. Duration of anaesthesia Titrate intraoperative fluid intraoperative, vasopressor and inotrope administration to variables acquired using standard anaesthetic monitoring. 30
Experimental Group Cardiac output monitoring group Measure cardiac output and derived variables continuously using non-invasive finger cuff technology. Duration of anaesthesia Titrate intraoperative fluid intraoperative, vasopressor and inotrope administration to measured variables. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant patients, 18 years of age and older, with the diagnosis of preeclampsia (as per the attending obstetrician), undergoing caesarean section delivery under spinal anaesthesia will be included in the study. Patients: -with fetal distress -unable to give informed consent (including failure to understand explanation of the study in English language) -who decline to participate -already on vasopressor therapy prior to arrival in theatre -with antepartum haemorrhage -expected to have general anaesthesia -converted from spinal to general anaesthesia intraoperatively -where there is deviation from the study protocol 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/02/2016 Univarsity of the Witwatersrand, Human Research Ethics Committee (Medical)
Ethics Committee Address
Street address City Postal code Country
Jubilee Road, Parktown Johannesburg 0000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the study is to document the effect of goal directed therapy using a non-invasive finger cuff cardiac output monitor on umbilical cord lactate in patients with preeclampsia, undergoing caesarean section delivery under spinal anaesthesia. Intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Charlotte Maxeke Johannesburg Academic Hospital Jubilee Road, Parktown Johannesburg 0000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Anaesthesiology Jubilee Road, Parktown Johannesburg 0000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anaesthesiology Jubilee Road, Parktown Johannesburg 0000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Catherine Hosking Jubilee Road, Parktown Johannesburg 0000 South Africa
Dr Ahmad Alli Jubilee Road, Parktown Johannesburg 0000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad Alli halothane@gmail.com +27114884344 Jubilee Road, Parktown
City Postal code Country Position/Affiliation
Joahnnesburg 0000 South Africa Specialist Anaesthesiologist
Role Name Email Phone Street address
Public Enquiries Catherine Hosking cath.hosking@gmail.com +27114884344 Jubilee Road, Parktown
City Postal code Country Position/Affiliation
Joahnnesburg 0000 South Africa Specialist Anaesthesiologist
Role Name Email Phone Street address
Scientific Enquiries Catherine Hosking cath.hosking@gmail.com +27114884344 Jubilee Road, Parktown
City Postal code Country Position/Affiliation
Joahnnesburg 0000 South Africa Specialist Anaesthesiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information