Cardiac Output in Preeclamptic

NCT05435573 | Completed

• 1 other identifier: ECHO
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography

Outcome Measures

Primary Outcomes (1)

• Cardiac output measurement

  1 hour post spinal anesthesia after administration of 1000 mL fluid using Transthoracic Echocardiography

  1 hour from the spinal anesthesia

Secondary Outcomes (5)

• Cardiac output measurement

  5 minutes after the 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

• Urine output volume

  1hour and 2 hours post spinal anesthesia

• Heart rate (HR)

  basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

• Mean Blood pressure

  basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

Study Arms (2)

Crystalloid group

ACTIVE COMPARATOR

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

Crystalloid-colloid group

ACTIVE COMPARATOR

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)

Interventions

1000 mL of ringer's acetate solution DRUG

1000 mL of ringer's acetate solution

Crystalloid group

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

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

Crystalloid-colloid group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Singleton pregnant preeclampsia scheduled for elective cesarean section delivery under spinal anesthesia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University-Emergency hospital-ICU

Al Mansurah, Mansoura, 35511, Egypt

Location

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives; HES 130-0.4

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All the fluids were prepared according to the group by an anesthetist who will not be involved in data collection. All the bottles were wrapped by opaque cover.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Model Details: Patients will be randomly allocated via sealed opaque envelops into 2 groups of 17 patients each; crystalloid group and group crystalloid-colloid group

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 28, 2022
• Study Start: August 17, 2022
• Primary Completion: September 15, 2023
• Study Completion: June 3, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)