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.: PACTR201511001361390 Date of Approval: 23/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title PiCCO vs. TED for fluid management is major surgery
Official scientific title Pulse-Induced Continuous Cardiac Output (PiCCO) versus Trans-Esophageal Doppler Monitor (TED) for Optimization of Fluid Management in Patients Undergoing Major Abdominal Surgery. A Comparative Study
Brief summary describing the background and objectives of the trial We designed this prospective, randomized study to evaluate the use of PiCCO system from the fluid and hemodynamic point of view in comparison to the TED in order to maintain an adequate circulatory volume ensuring end-organ perfusion and oxygen delivery to tissues. The primary outcome will be the postoperative morbidity based on number of infectious and other organ complications. Secondary outcome parameters will be the evaluation of two CO monitoring devices from many aspects to detect which is more accurate, easier to use, hospital/ ICU length of stay and all-cause mortality.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Major Abdominal Surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2014
Actual trial start date 10/11/2014
Anticipated date of last follow up 01/11/2015
Actual Last follow-up date 01/11/2015
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
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 randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PiCCO throughout the whole procedure throughout the whole procedure transpulmonary thermodilution (TP-TD) with 20 ml cold (4°C) saline and pulse contour measurements 36
Experimental Group TED throughout the whole procedure throughout the whole procedure Trans- oesophageal Doppler monitor TED measures the velocity of blood flow in the descending thoracic aorta 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Seventy two adult patients (ASA physical status II or III), of either sex, above age of 18 years old, undergoing major abdominal and pelvic surgery with expected duration more than 120 minutes and blood loss more than 1000 ml (e.g. radical cystectomy, radical prostatectomy, gasterectomy, pancreatectomy, splenectomy) 1.Age ¿ 18 years 2.Pregnant women 3.Esophageal pathology 4.Body weight less than 55 kg or more than 140 kg 5.Patients with uncontrolled diabetes or hypertension. 6.Irregular heart rhythm, advanced cardiac condition 7.Severe metabolic, neurologic, endocrinal, hepatic or renal impairment 8.Metastatic malignancies 9.Laparoscopic surgery 10.Contraindications for femoral arterial line insertion; stent, bypass or severe peripheral arterial occlusive disease 11.Coagulopathy or patients on anticoagulant or antiplatelet medications 19 Year(s) 100 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 Theodor Bilharz research Institute
Ethics Committee Address
Street address City Postal code Country
Kornish El-Nile Giza 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative morbidity based on number of infectious and other organ complications - end of surgery - 8 hours postoperatively - 24 hours postoperatively
Secondary Outcome the evaluation of two CO monitoring devices from many aspects to detect which is more accurate, easier to use, hospital/ ICU length of stay and all-cause mortality. at the end of hospital stay
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Theodor Bilharz Research Institute kornish El-Nile- warrak Giza 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Theodor Bilharz Research Institute Kornish El-Nile Giza 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Theodor Bilharz Research Institute Kornish El-Nile Giza 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hend F. Hassan Kornish El-Nile Giza 12345 Egypt
Mohamed Z. Ali Kornish El-Nile Giza 12345 Egypt
Ahmed I. Refaat Kornish El-Nile Giza 12345 Egypt
Mohamed A. Abdelhak kasr El-Ainy Medical School Cairo 11335 Egypt
Abla S. El-Hadidi Kornish El-Nile Giza 12345 Egypt
Nadia G. El-Sharkawy kasr El-Ainy Medical School Cairo 11335 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hend Fayed Hend10_fayed@hotmail.com +201005283829 Kornish El-Nile
City Postal code Country Position/Affiliation
Giza 12345 Egypt Assistant Lecturer Anesthesia and ICU. Theodor Bilharz Research Institute
Role Name Email Phone Street address
Public Enquiries Ahmed Refaat arefaat_ana@yahoo.com +201001710618 Kornish El-Nile
City Postal code Country Position/Affiliation
Giza 12345 Egypt Assistant Professor Anesthesia and ICU. Theodor Bilharz Research Institute
Role Name Email Phone Street address
Scientific Enquiries Mohamed Zeidan zeidanoma@hotmail.com +201111113115 82 Mannial Museum Street
City Postal code Country Position/Affiliation
Cairo 11335 Egypt Assistant Professor Anesthesia and ICU. Theodor Bilharz Research Institute
REPORTING
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