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.: PACTR201902530245620 Date of Approval: 15/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fluid therapy in intra-cranial surgeries
Official scientific title The effect of Cardiometry guided fluid management on the outcome of patients presented for intracranial surgeries: Randomized controlled study
Brief summary describing the background and objectives of the trial The perioperative fluid management of neurosurgical patients presents a special challenge to the anesthesiologists in the perioperative period. Intraoperative fluid management is important in preventing hypervolemia and its complications. There had been much debate in the literature about which intraoperative fluid regimen is best for patients undergoing major surgery, with many advocating restrictive, more liberal or goal-directed fluid regimens with the aim of improving patient outcomes. Restrictive regimens had been shown to be advantageous, reducing post-operative complications, whereas liberal fluid administration has been associated with fluid overload and complications such as mucosal edema and an increased risk of anastomotic breakdown. A novel noninvasive method of measuring cardiac output is thoracic bioreactance. The aim of this study will be to compare the fluid management of intracranial surgeries guided by electrical cardiometry (EC) versus the guidance with the routine parameters
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 02/03/2019
Actual trial start date
Anticipated date of last follow up 01/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A The fluid management of patients in this group will follow the routine management through 5 ml/kg/hr of a lactated ringer. Throughout the whole intraoperative period Fluid management will depend on the routine parameters as heart rate, mean arterial blood pressure, urine output and central venous pressure. Additional fluid bolus will be given in case of blood loss or mean arterial blood pressure less than 65 mmHg in form of crystalloid 4 ml/kg. The bolus of crystalloid fluids can be repeated considering the total doses not exceeding 20 ml/kg. If the bolus fluids exceed the 20 ml/kg and the patient still hypotensive, vasopressor will be administered. 35 Active-Treatment of Control Group
Experimental Group Group B Fluid maintenance will be set at 3 ml/kg/h of lactated ringer solution with an infusion pump, and fluid boluses (200 ml) will be allowed according to an FTc-based fluids algorithm protocol The whole intraoperative period Fluid maintenance will be set at 3 ml/kg/h of lactated ringer solution with an infusion pump, and fluid boluses (200 ml) will be allowed according to an FTc-based fluids algorithm protocol and the type of bolus fluids will be determined according to Transthoracic fluid content (TFC).vasopressors and inotropes will be given according to reading of EC reading of systemic vascular resistance (SVR) and index of contractility (I CON). 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age more than 21 years. Patients with GCS 15 (fully conscious). ASA physical status II or III. Patients refuse to participate in our study. Patients with BMI more than 35 or less than 25. Patients with cardiac arrhythmia (limitation to use stroke volume variation as an indicator of fluid responsiveness). Significant renal dysfunction (serum creatinine > 1.5 mg/dl). Severe heart failure (New York Heart Association classification 3 or 4). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 65 Year(s) Both
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 18/07/2018 Research Ethics Committee of the Tanta Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Algeish st Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ICU length of stay At the patient discharge from the intensive care
Secondary Outcome Postoperative complication During the postoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals 1 Algeish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sameh Abdelkhalik Ahmed Saied st Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospitals Al geish st Tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amgd shaaban Elsayed Mohammed Elsheikh Moheb Tanta 31511 Egypt
Sohair Moustafa Soliman Moheb st Tanta 31511 Egypt
Nagat Sayed Elshamaa Botros st Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amgad Elsheikh amgdshaaban123@gmail.com 00201096377883 Moheb st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Assistant lecture at the Department of Anesthesia and Intensive Care
Role Name Email Phone Street address
Scientific Enquiries SalahEldein Elsherif salahalsherif505@yahoo.com 00201020150330 Ibn Elfared st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Anesthesia and Intensive Care Tanta Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Fatheya Khalil Fatheya.khalil@magrabi.com 00201006685105 Elhelw st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Head of Human Resources department Magrabi Eye Hospital Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Can cardiometry guide the fluid therapy in patients undergoing craniotomy for a brain tumor and decrease the incidence of postoperative complications. Study Protocol The study will last at least 1 year (till February 2020) and its time frame can be extended to March 2021. The 28th-day mortality
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information