Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539026
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Inferior Vena Cava Collapsibility Index Guide for Preoperative Fluid Therapy in Preeclampsia
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None