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Cardiac Output in Preeclamptic

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05435573
Acronym
Coload
Enrollment
34
Registered
2022-06-28
Start date
2022-08-17
Completion date
2024-06-03
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography

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.

Interventions

DRUG1000 mL of ringer's acetate solution

1000 mL of ringer's acetate solution

DRUG250 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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Intervention 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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output measurement1 hour from the spinal anesthesia1 hour post spinal anesthesia after administration of 1000 mL fluid using Transthoracic Echocardiography

Secondary

MeasureTime frameDescription
Left ventricular end diastolic volume (LVEDV) measurement1 hour from the spinal anesthesiamilliliter
Urine output volume1hour and 2 hours post spinal anesthesiamilliliters
Cardiac output measurement5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesiaat baseline ,5 minutes after spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia
Heart rate (HR)basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hoursbeats per minute
Mean Blood pressurebasal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hoursmmHg

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026