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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2024-12-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pre-Eclampsia Hypotension Fluid Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

* 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

Study Groups

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IVCCI-guided fluid therapy

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Conventional fluid therapy

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No