Inferior Vena Cava Collapsibility Index Guide for Preoperative Fluid Therapy in Preeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAin Shams University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Critically ill pre-eclamptic patients for cesarean section
Disqualifiers
Patient refusal
severe cardiovascular disease ( ejection fraction < 40 mmHg ), tricuspid regurge.
contraindication for spinal anesthesia.
failure to perform spinal anesthesia.
Trial design
Design model
Parallel
Treatments tested in this trial
fluid therapy, 300 ml of crystalloid Ringer's solution.
Other intervention300 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: IVCCI-guided fluid therapyExperimental treatment 1 intervention
Group B: Conventional fluid therapyNo intervention 0 interventions
Trial outcomes
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.
Time frame
20 minutes after the spinal anesthesia injectionSecondary outcomes
1
occurrence of complication
occurrence of any complications such as pulmonary edema, need for intraoperative vasopressors.
Time frame
from spinal anesthesia till the delivery of the fetus, or within 30 minutes postspinal which comes firstSponsors and contacts
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Source ClinicalTrials.gov