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

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:

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

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
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
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
Left ventricular end diastolic volume (LVEDV) measurement
Time Frame: 1 hour from the spinal anesthesia
milliliter
1 hour from the spinal anesthesia
Urine output volume
Time Frame: 1hour and 2 hours post spinal anesthesia
milliliters
1hour and 2 hours post spinal anesthesia
Heart rate (HR)
Time Frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
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.

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

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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