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

NCT06539026 | Recruiting

• 1 other identifier: FMASU R146/2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Eclampsia; Hypotension; Fluid Overload

Outcome Measures

Primary Outcomes (1)

• post-spinal hypotension

  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.

  20 minutes after the spinal anesthesia injection

Secondary Outcomes (1)

• occurrence of complication

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

Study Arms (2)

IVCCI-guided fluid therapy

EXPERIMENTAL

the participants in this group will receive crystalloids according to the IVCCI assessment as follows: 1. If ≥ 50 % a bolus will be given 300 ml by dripping within 30 minutes, the fluid will be repeated by half the amount if needed to reach equal or less than 40% collapsibility. 2. If \< 50 % or B line finding in lung ultrasound no bolus will be given.

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

Conventional fluid therapy

NO INTERVENTION

the participants in this group will receive the standard regimen; no routine additional fluid within half an hour before surgery only the fixed maintenance of 80-100 ml/hr.

Interventions

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.

IVCCI-guided fluid therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill pre-eclamptic patients for cesarean section

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt, 11528, Egypt

RECRUITING

Related Publications (4)

• Chang YJ, Liu CC, Huang YT, Wu JY, Hung KC, Liu PH, Lin CH, Lin YT, Chen IW, Lan KM. Assessing the Efficacy of Inferior Vena Cava Collapsibility Index for Predicting Hypotension after Central Neuraxial Block: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Aug 31;13(17):2819. doi: 10.3390/diagnostics13172819.

  PMID: 37685357 BACKGROUND

• Gagne MP, Richebe P, Loubert C, Drolet P, Gobert Q, Denault A, Zaphiratos V. Ultrasound evaluation of inferior vena cava compression in tilted and supine term parturients. Can J Anaesth. 2021 Oct;68(10):1507-1513. doi: 10.1007/s12630-021-02051-w. Epub 2021 Jul 1.

  PMID: 34212308 BACKGROUND

• Hernandez CA, Reed KL, Juneman EB, Cohen WR. Changes in Sonographically Measured Inferior Vena Caval Diameter in Response to Fluid Loading in Term Pregnancy. J Ultrasound Med. 2016 Feb;35(2):389-94. doi: 10.7863/ultra.15.04036. Epub 2016 Jan 18.

  PMID: 26782160 BACKGROUND

• Pretorius T, van Rensburg G, Dyer RA, Biccard BM. The influence of fluid management on outcomes in preeclampsia: a systematic review and meta-analysis. Int J Obstet Anesth. 2018 May;34:85-95. doi: 10.1016/j.ijoa.2017.12.004. Epub 2017 Dec 20.

  PMID: 29398426 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Hypotension; Edema

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

wessam selima, MD

CONTACT

01001958858; w.z.selima@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: * The care provider intraoperative; both the anesthesiologist and the obstetrician will be blinded regarding the intervention. * The anesthetic residents who will assess the outcome of hypotension are blind regarding the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a prospective, randomized, parallel-group, superior, controlled single-blinded clinical study

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: August 15, 2024
• Primary Completion: November 29, 2024
• Study Completion: December 20, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publishing the protocol in a relevant journal. will be available through that journal and according to the regulation
• Access Criteria: the published protocol will be either free or through a subscription according to the journal.

Locations

EG (1)