Cardiac Output in Preeclamptic

Not Applicable

Recruiting

• Conditions: Echocardiography
• Interventions: Drug: 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven); Drug: 1000 mL of ringer's acetate solution

• Registration Number: NCT05435573
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-28
• Study Start: 2022-08-17
• Primary Completion: 2023-09-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 34

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).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalloid-colloid group	250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)	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
Crystalloid group	1000 mL of ringer's acetate solution	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).

Primary Outcome Measures

Name	Time	Method
Cardiac output measurement	1 hour from the spinal anesthesia	1 hour post spinal anesthesia after administration of 1000 mL fluid using Transthoracic Echocardiography

Secondary Outcome Measures

Name	Time	Method
Urine output volume	1hour and 2 hours post spinal anesthesia	milliliters
Cardiac output measurement	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
Left ventricular end diastolic volume (LVEDV) measurement	1 hour from the spinal anesthesia	milliliter
Heart rate (HR)	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours	beats per minute
Mean Blood pressure	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours	mmHg

Trial Locations

Locations (1)

Mansoura University-Emergency hospital-ICU; 🇪🇬 Mansoura, Egypt