- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435573
Cardiac Output in Preeclamptic (Coload)
October 19, 2023 updated by: maha abou-zeid, Mansoura University
Coload Effect on Cardiac Output Measurement Using Transthoracic Echocardiography in Preeclamptic Patients Undergoing Cesarean Delivery
There is high incidence of hypertensive disorders during pregnancy.The maternal cardiovascular system had significant changes during pregnancy.
The colloid oncotic pressure is decreased during preeclampsia.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Transthoracic echocardiography considered an accurate non-invasive device and has validity for measuring cardiac functions in pregnancy.
Study Type
Interventional
Enrollment (Estimated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mansoura, Egypt, 35511
- Recruiting
- Mansoura University-Emergency hospital-ICU
-
Contact:
- Maha Abozeid, MD
- Phone Number: 00201019216192
- Email: Mahazed@mans.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pre-eclampsia
- Age 18-45 years.
- Singleton pregnancy scheduled for elective CS delivery under spinal anesthesia.
- American Society of Anesthesiologists (ASA Ⅱ, Ⅲ).
Exclusion Criteria:
- Body mass index < 18 or ≥40 kg/m²
- Women presenting in labor
- Current administration of vasoactive drugs including salbutamol and thyroxin.
- Diabetes mellitus.
- Hemoglobin <10 g/dl.
- Cardiovascular, cerebrovascular, or renal disease
- Increased serum creatinine level ≥1.1 mg/dL.
- Contraindications to spinal anesthesia:(increased intracranial pressure, coagulopathy, or local skin infection)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Crystalloid group
The patients will receive 1000 mL of ringer's acetate solution (250 mL over 5 minutes starting immediately after intrathecal injection using a pressurizer then 500 mL over 55 minutes then 250 mL over 60 minutes).
|
1000 mL of ringer's acetate solution
|
Active Comparator: Crystalloid-colloid group
Patients will receive 250 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride starting immediately after intrathecal injection then 500 mL of ringer's acetate solution then 250 mL of hydroxyethyl starch
|
500 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride plus 500 mL of ringer's acetate solution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output measurement
Time Frame: 1 hour from the spinal anesthesia
|
1 hour post spinal anesthesia after administration of 1000 mL fluid using Transthoracic Echocardiography
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1 hour from the spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output measurement
Time Frame: 5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia
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at baseline ,5 minutes after spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia
|
5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia
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Left ventricular end diastolic volume (LVEDV) measurement
Time Frame: 1 hour from the spinal anesthesia
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milliliter
|
1 hour from the spinal anesthesia
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Urine output volume
Time Frame: 1hour and 2 hours post spinal anesthesia
|
milliliters
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1hour and 2 hours post spinal anesthesia
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Heart rate (HR)
Time Frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
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beats per minute
|
basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
|
Mean Blood pressure
Time Frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
|
mmHg
|
basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2022
Primary Completion (Actual)
September 15, 2023
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
June 17, 2022
First Submitted That Met QC Criteria
June 23, 2022
First Posted (Actual)
June 28, 2022
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 19, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECHO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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