Cardiac Output in Preeclamptic

NCT ID: NCT05435573

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2024-03-01

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.

Conditions

Echocardiography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

1000 mL of ringer's acetate solution

Intervention Type: DRUG

1000 mL of ringer's acetate solution

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

500 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride plus 500 mL of ringer's acetate solution

Interventions

1000 mL of ringer's acetate solution

1000 mL of ringer's acetate solution

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University-Emergency hospital-ICU

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Maha Abozeid, MD

Role: primary

mahazed@mans.edu.eg

00201019216192

Other Identifiers

ECHO

Identifier Type: -

Identifier Source: org_study_id