Transthoracic Echocardiographic Monitoring of Cardiac Output Effects of Colloid Preload and Crystalloid Coload During Cesarean Delivery Under Spinal Anesthesia

NCT06654687 | Completed

• 1 other identifier: ECHO for CO monitoring in CD
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Transthoracic echocardiography (TTE) has been introduced in anesthesia and intensive care practice to assess the volume status and predict fluid responsiveness, with a few studies performed on pregnant women (5). In this study, we aim to evaluate the effect of intravenous administration of albumin as a colloid preload on the maternal stroke volume (SV) and cardiac output (CO) versus crystalloid coload. We used TTE to measure the changes in SV, and CO at baseline and at subsequent time points after spinal anesthesia.

Conditions

Pregnancy; Cesarean Delivery; Spinal Anesthesia Induced Hypotension; Cardiac Output Measurement; Volume Status

Keywords

Cardiac output- Transthoracic ECHO - Colloids - Crystalloids - Cesarean delivery - Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Changes in Cardiac Output

  The changes in Cardiac Output are measured relative to baseline immediately after delivery

  Immediately after delivery of baby

Secondary Outcomes (9)

• Changes in stroke volume

  Immediately after delivery of baby

• Total phenylephrine dose (mg)

  Until delivery of baby

• Total ephedrine dose (mg)

  Until delivery of the baby

• Total glycopyrrolate dose (mg)

  Until delivery of the baby

• Incidence of hypotension

  Until end of surgery

Study Arms (2)

Crystalloid group

ACTIVE COMPARATOR

Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output. Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes.

Device: Transthoracic Echocardiography; Drug: Ringer lactate 1000 ml

Combination group

ACTIVE COMPARATOR

Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output. Patients will receive 250 mL of human albumin 5% over 10 minutes and 750 mL of Ringer's lactate solution over 15 minutes.

Device: Transthoracic Echocardiography; Drug: Albumin; Drug: Ringer lactate 750 ml

Interventions

Transthoracic Echocardiography DEVICE

Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.

Combination group; Crystalloid group

Ringer lactate 1000 ml DRUG

Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes.

Crystalloid group

Albumin DRUG

Patients will receive 250 mL of human albumin 5% over 10 minutes

Combination group

Ringer lactate 750 ml DRUG

Patients will receive 750 mL of Ringer's lactate solution over 15 minutes.

Combination group

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status II parturients with full term singleton pregnancies scheduled for elective cesarean delivery under spinal anesthesia.

You may not qualify if:

• Height \<150 cm, weight \<55 kg, and body mass index ≥40 kg/m2.
• Women presenting in labor or having any contraindication to spinal anesthesia (patient refusal, increased intracranial pressure, coagulation disorders, or local skin infection).
• Chronic or pregnancy-induced hypertension; baseline systolic blood pressure \>140 mm Hg.
• Hemoglobin \<10 g/dL.
• Diabetes mellitus.
• Cardiovascular, cerebrovascular, or renal disease.
• Polyhydramnios or fetal abnormalities.

Sponsors & Collaborators

• Sameh Fathy: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

Related Publications (6)

• Porter TR, Shillcutt SK, Adams MS, Desjardins G, Glas KE, Olson JJ, Troughton RW. Guidelines for the use of echocardiography as a monitor for therapeutic intervention in adults: a report from the American Society of Echocardiography. J Am Soc Echocardiogr. 2015 Jan;28(1):40-56. doi: 10.1016/j.echo.2014.09.009. No abstract available.

  PMID: 25559474 BACKGROUND

• Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.

  PMID: 20620859 BACKGROUND

• McDonald S, Fernando R, Ashpole K, Columb M. Maternal cardiac output changes after crystalloid or colloid coload following spinal anesthesia for elective cesarean delivery: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):803-10. doi: 10.1213/ANE.0b013e31822c0f08. Epub 2011 Sep 2.

  PMID: 21890886 BACKGROUND

• Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.

  PMID: 26580836 BACKGROUND

• Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.

  PMID: 21948275 BACKGROUND

• Loubert C. Fluid and vasopressor management for Cesarean delivery under spinal anesthesia: continuing professional development. Can J Anaesth. 2012 Jun;59(6):604-19. doi: 10.1007/s12630-012-9705-9. Epub 2012 Apr 24. English, French.

  PMID: 22528166 BACKGROUND

MeSH Terms

Interventions

Echocardiography; Ringer's Lactate; Albumins

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MOHAMED TOLBA ELMORSY, MD

  Lecturer of Anesthesia and ICU - Faculty of Medicine - Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and ICU - Faculty of Medicine - Mansoura University

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 27, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

EG (1)