Cardiac Output in Preeclamptic

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

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

Conditions
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Echocardiography

Intervention / Treatment
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* Drug: 1000 mL of ringer's acetate solution
* Drug: 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly allocated via sealed opaque envelops into 2 groups of 17 patients each; crystalloid group and group crystalloid-colloid group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crystalloid group<br>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). | Drug: 1000 mL of ringer's acetate solution<br>* 1000 mL of ringer's acetate solution<br>|
| Active Comparator: Crystalloid-colloid group<br>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 | Drug: 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)<br>* 500 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride plus 500 mL of ringer's acetate solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output measurement | 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 | 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 | milliliter | 1 hour from the spinal anesthesia | 
| Urine output volume | milliliters | 1hour and 2 hours post spinal anesthesia | 
| Heart rate (HR) | beats per minute | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours | 
| Mean Blood pressure | mmHg | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours |