Fluid Overload, Hypotension, Pre-Eclampsia
Conditions
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.
Detailed description
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.
Interventions
OTHERfluid 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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
* 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
Intervention model description
a prospective, randomized, parallel-group, superior, controlled single-blinded clinical study
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-spinal hypotension | 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
| Measure | Time frame | Description |
|---|---|---|
| occurrence of complication | 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. |
Countries
Egypt
Contacts
Primary Contactwessam selima, MD
Outcome results
None listed