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.: PACTR202211489398809 Date of Approval: 02/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Conventional fluid management versus Goal directed fluid management
Official scientific title Conventional fluid management versus Goal directed fluid management in elective colorectal surgery
Brief summary describing the background and objectives of the trial Intraoperative fluid management is important in terms of postoperative organ perfusion and complications. Accurate assessment of a patient’s volume status is an important goal for the anesthetist in the operating theatre to achieve hemodynamic stability and adequate tissue oxygenation. Different intraoperative fluid management protocols are in use for this purpose. objectives of trial to compare of intraoperative goal directed fluid therapy (GDFT) versus conventional fluid therapy in patients undergoing elective colorectal surgery using noninvasive electrical cardiometry
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/01/2020
Actual trial start date 03/03/2020
Anticipated date of last follow up 02/01/2022
Actual Last follow-up date 03/02/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group 2 Conventional fluid therapy group The infusion started with ringer acetate solution after induction according to fasting period and maintenance and 3rd space loss according to surgical incision usually at the rate of 6–8 ml/kg/h according to the routine techniques by taking the parameters such as HR, mean arterial pressure (MAP), CVP and urine output into consideration all over surgical duration The infusion started with ringer acetate solution after induction according to fasting period and maintenance and 3rd space loss according to surgical incision usually at the rate of 6–8 ml/kg/h at colorectal surgery. The intraoperative fluid infusion according to the routine techniques by taking the parameters such as HR, mean arterial pressure (MAP), CVP and urine output into consideration. Hypotension defined as a condition in which the MAP was below 65 mmHg or 30% below the baseline MAP of the patient. In this case, the speed of crystalloid infusion was increased, colloid (6% hydroxy ethyl starch 130/ 0.4 ) infusion initiated and in case of hypotension persistence, blood were given according to blood loss and to maintain Hb level >10 g/ dl 50 Active-Treatment of Control Group
Experimental Group group 2 Goal directed fluid therapy group Basal stroke volume and stroke volume variation was recorded . 200 ml of Colloid 6% hydroxy ethyl starch 130/ 0.4 was infused over 10 minutes and stroke volume response was recorded. If stroke volume increased by more than 10 % for 20 minutes, the bolus will be repeated. No further colloid was given once stroke volume failed to increase more than 10% all over surgical duration The last stroke volume with higher 10% response will be defined as maximum stroke volume (SVmax). When stroke volume decreased intraoperatively by 10% below (SVmax), this will be defined as trigger stroke volume (SVT).Intravenous fluids were infused to maintain stroke volume variation between (8-12 %). If stroke volume variation is less than (8%), I.V crystalloids administration rate was decreased. If stroke volume variation is increased above (12%) I.V crystalloids administration rate was increased . Blood loss more than 500ml was replaced in 1:1 ratio. Blood loss less than 500 ml was replaced by ringer solution. If there was a reduction in stroke volume below SVt, infusion of 200 ml hydroxy ethyl starch 130/0.4 is started and this infusion was repeated for 3 times before considering giving the patient inotropes according to other cardiac parameters 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients scheduled for elective colorectal surgery Age between 21 - 65 years. Gender: either male or female. American Society of Anesthesiology (ASA): I&II patients. Hb >10 g/dl & Hct >33% Patient refusal Patients with major cardiovascular problems ( ejection fraction < 45 %) Renal impairment with serum creatinine >1.8 mg/dl . Patients with hepatic dysfunction (Child Pugh B or C ) Bleeding and coagulation problems. Metabolic disorder, serum lactate > 2 mmol/L Adult: 19 Year-44 Year,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 01/04/2019 Institutional Review Board faculty of medicine Mansoura university
Ethics Committee Address
Street address City Postal code Country
elgomhoria street mansoura 19.03.163 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum lactate, and serum creatinine levels. end of surgery, 6h, 24h, 48h postoperative
Secondary Outcome Hemodynamic variables including stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), and thoracic fluid content (TFC) were measured by Cardiac output non-invasive monitor after induction of anesthesia T1, at 30min T2, 2 hrs. T3, 3 hrs.T4 and 4 hrs.T5 intraoperative
Secondary Outcome MBP, heart rate intraoperative after induction of anesthesia, 30min, 2 hrs., 3 hrs. and 4 hrs. postoperative at 6,12, 24 h
Secondary Outcome Volumes of fluid administered either crystalloid, colloid, blood or blood products, Hypotensive episodes, total dose of ephedrine and number of patient needed vasopressor at end of surgery
Secondary Outcome postoperative complication as wound dehiscence, burst abdomen, acute kidney injury 5 days postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura oncology center Elgomhoria street mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university Elgomhoria street mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university elgomhoria street Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelrahman Mahmoud Abdelrahman x-scorpion1@hotmail.com 01007488393 Elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Abdelrahman M. abdelrahman
Role Name Email Phone Street address
Public Enquiries Rania Elmohamady Elbadrawy raniaelmohamady@gmail.com 01128819560 Elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Rania E. Elbadrawy
Role Name Email Phone Street address
Scientific Enquiries Amgad Zaghloul a_zaghloul_eg@mans.edu.eg 01002414795 Elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Amgad A. Zaghloul
Role Name Email Phone Street address
Scientific Enquiries Aboelnour Elmorsy Badran abadran@mans.edu.eg 01227380257 Elgomhoria
City Postal code Country Position/Affiliation
mansourah Egypt Aboelnour E. Badran
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intended sharing of individual trial participant data within 12 months of the study completion date with a researcher covered with institutional review board Informed Consent Form,Statistical Analysis Plan within 12 months of the study completion date controlled any researcher or organization covered by ethical committee can have access to data after request of author
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