Coload: Cardiac Output in Preeclamptic

• Sponsor: Mansoura University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05435573
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.5
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Echocardiography	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)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 groupPatients will be randomly allocated via sealed opaque envelops into 2 groups of 17 patients each; crystalloid group and group crystalloid-colloid group
• Masking: Double (Participant, 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.
• Primary Purpose: Treatment
• Official Title: Coload Effect on Cardiac Output Measurement Using Transthoracic Echocardiography in Preeclamptic Patients Undergoing Cesarean Delivery
• Anticipated Study Start Date: Sep 15, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	Drug: 1000 mL of ringer's acetate solution; 1000 mL of ringer's acetate solution
Active Comparator: 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	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

Outcome Measures

Primary Outcome Measures

1. Cardiac output measurement [1 hour from the spinal anesthesia]

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

Secondary Outcome Measures

1. Cardiac output measurement [5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia]

   at baseline ,5 minutes after spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia

2. Left ventricular end diastolic volume (LVEDV) measurement [1 hour from the spinal anesthesia]

   milliliter

3. Urine output volume [1hour and 2 hours post spinal anesthesia]

   milliliters

4. Heart rate (HR) [basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours]

   beats per minute

5. Mean Blood pressure [basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours]

   mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University-Emergency hospital-ICU	Mansoura		Egypt	35511

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: maha abou-zeid, Assistant Professor of Anesthesia and Surgical Intensive Care, Mansoura University
• ClinicalTrials.gov Identifier: NCT05435573
• Other Study ID Numbers: ECHO
• First Posted: Jun 28, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hydroxyethyl Starch Derivatives; Pharmaceutical Solutions

Study Results

No Results Posted as of Aug 24, 2022