Cardiac Output in Preeclamptic (Coload)

Mansoura University

Status: Enrolling

Conditions: Echocardiography

Treatments: 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT05435573

ECHO

Details and patient eligibility

About

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.

Full description

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

Enrollment: 34 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

34 participants in 2 patient groups

Crystalloid group

Active Comparator group

Description:

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).

Treatment:

Drug: 1000 mL of ringer's acetate solution

Crystalloid-colloid group

Active Comparator group

Description:

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

Treatment:

Drug: 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)