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.: PACTR202103623159030 Date of Approval: 29/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of intraoperative restrictive fluid therapy versus goal directed fluid therapy on postoperative pulmonary complications in sitting or prone neurosurgical patients
Official scientific title Effect of intraoperative restrictive fluid therapy versus goal directed fluid therapy on postoperative pulmonary complications in sitting or prone neurosurgical patients
Brief summary describing the background and objectives of the trial Perioperative fluid therapy has been studied extensively, but the optimal strategy remains controversial and uncertain The major aims with fluid therapy for neurosurgical procedures are to minimize the risk for inadequate cerebral perfusion pressure (CPP) and to maintain good neurosurgical conditions. Excessive fluid restriction to minimize cerebral edema may lead to hemodynamic instability. Patient positioning, especially sitting and prone positions, may also promote hemodynamic changes Excessive fluid administration can cause increased extravascular fluid in the lung tissue and pulmonary edema, which can impair oxygen exchange and increase the risk of postoperative respiratory failure and pneumonia, Electrical cardiometry (EC), a more recent version of impedance cardiography (ICG), meets the criteria for an ideal CO monitor, The aim of this work is to compare the fluid management in sitting or prone neurosurgical patients with expected marked fluid shift guided by electrical cardiometry (EC) versus the use of the restrictive regimen.
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 Diagnosis / Prognosis
Anticipated trial start date 01/04/2021
Actual trial start date
Anticipated date of last follow up 01/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Completed
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intraoperative restrictive fluid therapy during the surgery • During the intraoperative period, patients will receive a balanced electrolyte crystalloid solution (e.g. Lactated ringer's) administered at a rate of 3 mL/kg/h to replace the sensible and insensible losses(16). • For blood loss, additional fluid may be administered in ratio of 1.5:1.0 for crystalloid , or 1:1 for colloids , until a threshold for red blood cell (RBC) transfusion is reached Fluid management will depend on the routine parameters as heart rate, mean arterial blood pressure, urine output and central venous pressure. If the patient still hypotensive (mean arterial blood pressure less than 65 mmHg) after replacement of fluid and blood loss ----→ vasopressor (norepinephrine) will be administered to ensure adequate perfusion to vital organs. • Baseline reading of SVV (10 min. before induction) will be recorded and then every 30 min. till the end of operation. 35
Control Group Cardiometry guided goal directed fluid therapy during the surgery Fluid maintenance will be set at 3 ml/kg/h of lactated ringerʹs solution will be delivered with an infusion pump. After recording baseline SVV and cardiac index (CI) reading, SVV will be evaluated every 10 minutes, and fluid boluses (250 ml) will be allowed according to SVV 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 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Participants: adult patients aged 21 – 60 years.  Inclusion criteria • Patients scheduled for neurosurgery in abnormal position (sitting or prone) with expected marked fluid shift. • Age from 21 to 60 years old. • Patients with GCS 15 (fully conscious). • ASA physical status II or III. • Competence to consent. • 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). • Severe uncontrolled pulmonary disease. • Non-extubated patients. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 60 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 21/04/2021 Research Ethics Committee faculty of medicine tanta university
Ethics Committee Address
Street address City Postal code Country
Geesh street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lung ultrasound score 30 min. before induction of anesthesia, 30 min. postoperative in PACU and at the end of the first 24 hours in ICU.
Secondary Outcome total intraoperative fluid requirements, number of fluid boluses, number of patients requiring vasopressors, and urine output, postoperative pulmonary complications, postoperative morbidity (the proportion of patients who developed one or more complications), and ICU length of stay. Postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University hospitals in neurosurgery department geesh street tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Reda Elreweny Qurashya santa gharbya Qurashya 31747 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia department faculty of medicine tanta university GEESH STREET TANTA 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hoda Alsaid Ahmed Ezz 46 salah eldin street Tanta 31511 Egypt
Jehan Mohamad Ezzat Darwish 6 mostafa kamel street Tanta 31511 Egypt
Ahmed Reda Osman Elreweny Qurashya Elsanta gharbya governorate 31747 Egypt
Maram Ibrahem Elmazny 2 alfateh street Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hoda Alsaid Ahmed Ezz hodaezz714@yahoo.com 01095589259 46 salah eldin street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Anesthesiology and surgical ICU and pain medicine faculty of medicine tanta university
Role Name Email Phone Street address
Scientific Enquiries Hoda Alsaid Ahmed Ezz hodaezz714@yahoo.com 01095589259 46 salah eldin street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of anesthesiology and surgical ICU and pain medicine faculty of medicine tanta university
Role Name Email Phone Street address
Public Enquiries Kamal Heikal kamal.hekal@med.tanta.edu.eg 01223446472 Mahalla Kubra gharbya governorate
City Postal code Country Position/Affiliation
Mahalla Kubra 31951 Egypt Professor of anesthesiology and surgical ICU and pain medicine faculty of medicine tanta university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1) Demographic data will be recorded [age (years), gender, height (cm), weight (kg), BMI (kg/m2) and type of surgery, duration of surgery, ASA and comorbidities]. 2) LUS baseline preoperative and postoperative in PACU for both groups to evaluate the number of patients with score more than 3 in the two groups 3) Baseline reading of SVV (10 min. before induction) in both groups 4) Subsequent readings of SVV in both groups (A and B) every 30 min. till end of operation. 6) Length of ICU and hospital stay will be recorded. 7) The total amount of infused volume of crystalloid solutions, colloid and blood products that will be given to patients during surgery. 8) Heart rate, mean arterial pressure, percutaneous arterial oxygen saturation, will be also recorded during the surgery baseline reading (10 min. before induction) every 30 min. till end of operation. 9) The number of patients who need vasoactive (dopamine or/and norepinephrine (noradrenaline) support more than two hrs. in the two groups will also be recorded. 10) The number of patients with increased postoperative LUS by 3 or more will be compared between the two groups. 11) Postoperative complications in each group will be recorded as, pneumonia, pulmonary embolism, coma, brain edema, sepsis, number of patients who need ventilator support, acute kidney injury, renal failure, stroke, deep vein thrombosis, skin infection or arrhythmia. Informed Consent Form,Study Protocol One year after approval of Ethical Committee controlled access
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
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