Cardiac Output in Preeclamptic

Echocardiography Clinical Trial

— Coload  

Official title:

Coload Effect on Cardiac Output Measurement Using Transthoracic Echocardiography in Preeclamptic Patients Undergoing Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435573
• Other study ID #: ECHO
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Transthoracic echocardiography considered an accurate non-invasive device and has validity for measuring cardiac functions in pregnancy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: March 1, 2024
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pre-eclampsia
• Age 18-45 years.
• Singleton pregnancy scheduled for elective CS delivery under spinal anesthesia.
• American Society of Anesthesiologists (ASA ?, ?).

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)

Related Conditions & MeSH terms

• Echocardiography

Intervention

Drug:
• 1000 mL of ringer's acetate solution
1000 mL of ringer's acetate solution
• 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)
500 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride plus 500 mL of ringer's acetate solution

Locations

Country	Name	City	State
Egypt	Mansoura University-Emergency hospital-ICU	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output measurement	1 hour post spinal anesthesia after administration of 1000 mL fluid using Transthoracic Echocardiography	1 hour from the spinal anesthesia
Secondary	Cardiac output measurement	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
Secondary	Left ventricular end diastolic volume (LVEDV) measurement	milliliter	1 hour from the spinal anesthesia
Secondary	Urine output volume	milliliters	1hour and 2 hours post spinal anesthesia
Secondary	Heart rate (HR)	beats per minute	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Secondary	Mean Blood pressure	mmHg	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours