Actively Recruiting

Phase Not Applicable
FEMALE
ID06539026

Ultrasound Assessment of Inferior Vena Cava Collapsibility Index to Guide Pre-operative Fluid Management in Critically Ill Pre-eclamptic Patients Compared with Standard Fluid Management

Led by Ain Shams University · Updated on 2024-10-29

90

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating fluid management strategies in critically ill patients with pre-eclampsia undergoing cesarean section. Pre-eclampsia is a serious pregnancy complication involving high blood pressure that can lead to severe outcomes for both mother and baby. This trial aims to compare the use of ultrasound-based measurement of the Inferior Vena Cava Collapsibility Index (IVCCI) to guide fluid therapy against the standard fluid management based on clinical evaluation in this high-risk group. In this study, participants are randomly assigned to one of two groups. The experimental group receives fluid therapy guided by IVCCI assessed using ultrasound, where fluid is administered as 300 ml of crystalloid Ringer's solution over 30 minutes and repeated if needed based on IVCCI values. The control group receives the conventional fluid regimen without additional fluids before surgery, maintaining a fixed rate of 80-100 ml/hour. The trial evaluates the safety and effectiveness of these approaches during the perioperative period. During the study, researchers monitor participants closely for post-spinal hypotension occurring within 20 minutes after spinal anesthesia and any complications arising from spinal anesthesia until delivery or within 30 minutes after spinal anesthesia, whichever occurs first. This includes using ultrasound assessments, clinical monitoring, and recording fluid responsiveness. The study ensures careful observation of maternal fluid status and blood pressure to assess outcomes, with participation spanning the preoperative and operative periods for cesarean section.

CONDITIONS

Brief Title

Inferior Vena Cava Collapsibility Index Guide for Preoperative Fluid Therapy in Preeclampsia

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Critically ill pre-eclamptic patients scheduled for cesarean section
Not Eligible

You will not qualify if you...

  • Patient refusal
  • Severe cardiovascular disease such as ejection fraction below 40 mmHg or tricuspid regurgitation
  • Contraindication for spinal anesthesia
  • Failure to perform spinal anesthesia
  • Severe liver disease
  • Renal dysfunction

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 30 minutes before surgery

Participants receive fluid therapy guided either by ultrasound assessment of the inferior vena cava collapsibility index or by standard clinical fluid management before cesarean section.

1 preoperative visit (in-person)

Trial Site Locations

Total: 1 location

1

Ain shams university

Cairo, Egypt, Egypt, 11528

Actively Recruiting

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Research Team

W

wessam selima, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Assessing the Efficacy of Inferior Vena Cava Collapsibility Index for Predicting Hypotension after Central Neuraxial Block: A Systematic Review and Meta-Analysis.

Ying-Jen Chang, Chien-Cheng Liu, Yen-Ta Huang...

https://pubmed.ncbi.nlm.nih.gov/37685357

Changes in Sonographically Measured Inferior Vena Caval Diameter in Response to Fluid Loading in Term Pregnancy.

Celso A Hernandez, Kathryn L Reed, Elizabeth B Juneman...

https://pubmed.ncbi.nlm.nih.gov/26782160