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NCT Number: NCT06539026

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

The routine assessment of fluid status depends on clinical evaluation and invasive monitoring. The clinical assessment lacks objectivity and the invasive monitoring carries risks. Point of care ultrasound (POCUS) parameters can be useful as early markers of fluid status and were used in safe fluid assessment in term pregnancy and preeclampsia.

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Key information

Conditions

Pre-eclampsia Cardiovascular Diseases Edema Female Urogenital Diseases and Pregnancy Complications Fluid Overload Hypertension, Pregnancy-Induced Hypotension Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, Egypt, 11528

Location status: Recruiting

Location contact

Anesthesia department

CONTACT

[email protected]

01009499962

About this study

Fluid therapy in preeclamptic patients presents a challenge. volume expansion may precipitate pulmonary edema while fluid restriction may worsen renal function and may aggravate post-spinal hypotension during cesarean section.

Pre-eclampsia predisposes to maternal mortality. It presents a serious hypertensive disorder during pregnancy which may progress rapidly to serious complications, including the death of both mother and fetus The optimal fluid management strategy constitutes a cornerstone in the management. The Royal College of Obstetricians and Gynecologists (RCOG) guidelines for severe pre-eclampsia recommend restrictive fluid therapy, in keeping with the absence of evidence favoring volume expansion. Restrictive management is advocated by The Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) with additional fluid administration only recommended before intravenous hydralazine, regional anesthesia, immediate delivery, or in oliguric patients where a volume deficit is suspected.

Overall, limited evidence exists regarding the effectiveness of ultrasound assessment of the IVC collapsibility index to guide pre-operative fluid management in critically ill pre-eclamptic patients. A meta-analysis stated that few research trials are available in the obstetric population. Some studies suggest that it can accurately predict fluid responsiveness, but others argue that it may not be helpful.

Our trial is the first trial that compares the efficacy of IVCCI-guided perioperative fluid therapy against standard fluid therapy guided by clinical parameters in critically ill pre-eclamptic patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Critically ill pre-eclamptic patients for cesarean section

Exclusion criteria

  • Patient refusal
  • severe cardiovascular disease ( ejection fraction < 40 mmHg ), tricuspid regurge.
  • contraindication for spinal anesthesia.
  • failure to perform spinal anesthesia.
  • severe hepatic.
  • renal dysfunction

Treatment and study plan

fluid therapy, 300 ml of crystalloid Ringer's solution.

Other

300 ml by dripping within 30 minutes, the fluid will be repeated by half the amount if needed to reach equal or less than 50% collapsibility.

the fluid that will be used is sterile Ringer's solution which is an isotonic intravenous solution with pH 5.0 - 7.5 and an osmolality of 308mOsmol/kg.

Primary outcomes

  1. post-spinal hypotension

    Time frame: 20 minutes after the spinal anesthesia injection

    post-spinal anesthesia and early intraoperative (0-20 min) hypotension (MAP < 65 mmHg and/or ≥ 20% decrease from baseline. Measured by the occurrence or not of hypotension.

    The aggregation method will be according to the distribution of data if normal mean and SD will be used.

Secondary outcomes

  1. occurrence of complication

    Time frame: from spinal anesthesia till the delivery of the fetus, or within 30 minutes postspinal which comes first

    occurrence of any complications such as pulmonary edema, need for intraoperative vasopressors.

Study contacts

Contact information is provided by the study sponsor or research team.

wessam selima, MD

CONTACT

[email protected]

01001958858

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ultrasound Assessment of Inferior Vena Cava Collapsibility Index (IVCCI) to Guide Pre-operative Fluid Management in Critically Ill Pre-eclamptic Patients in Comparison with the Standard Fluid Management

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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