Pre-EclampsiaNCT06539026
Inferior Vena Cava Collapsibility Index Guide for Preoperative Fluid Therapy in Preeclampsia
A study testing fluid therapy, 300 ml of crystalloid Ringer's solution. in people with Pre-Eclampsia and Hypotension, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pre-Eclampsia, Hypotension, Fluid Overload
- What is being tested?
- fluid therapy, 300 ml of crystalloid Ringer's solution.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Critically ill pre-eclamptic patients for cesarean section
Who cannot join
- Patient refusal
- severe cardiovascular disease ( ejection fraction < 40 mmHg ), tricuspid regurge.
- contraindication for spinal anesthesia.
- failure to perform spinal anesthesia.
- severe hepatic.
- renal dysfunction
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, Egypt, 11528
Anesthesia department, 01009499962, anesth_office@med.asu.edu.eg
About this study
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
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.
Read the 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.
- Conditions
- Pre-Eclampsia, Hypotension, Fluid Overload
- Being tested
- fluid therapy, 300 ml of crystalloid Ringer's solution.
- Medical subject headings
- Pre-Eclampsia, Hypotension, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes after the spinal anesthesia injection
Secondary outcomes (1)
occurrence of complication
occurrence of any complications such as pulmonary edema, need for intraoperative vasopressors.
Measured: from spinal anesthesia till the delivery of the fetus, or within 30 minutes postspinal which comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start15 Aug 2024
- Primary completion29 Nov 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective, randomized, parallel-group, superior, controlled single-blinded clinical study
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539026
- Sponsor's protocol ID
- FMASU R146/2024
- Status last verified
- Jul 2024
- First submitted
- 1 Aug 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified individual participant data (IPD) will be available to other researchers
Publications
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.
PubMed 37685357Gagne 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.
PubMed 34212308Hernandez 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.
PubMed 26782160Pretorius 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.
PubMed 29398426
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06539026
- Acronym / sponsor ID
- FMASU R146/2024
- Conditions
- Pre-Eclampsia, Hypotension, Fluid Overload
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- a prospective, randomized, parallel-group, superior, controlled single-blinded clinical study
| Arm | Type | Receives |
|---|---|---|
| IVCCI-guided fluid therapy | Experimental | Other: fluid therapy, 300 ml of crystalloid Ringer's solution.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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill pre-eclamptic patients for cesarean section
Key exclusion criteria (6 listed)
- Patient refusal
- severe cardiovascular disease ( ejection fraction < 40 mmHg ), tricuspid regurge.
- contraindication for spinal anesthesia.
- failure to perform spinal anesthesia.
- severe hepatic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | IVCCI-guided fluid therapy |
Primary outcome
post-spinal hypotension
Time frame: 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.
1 secondary outcome
occurrence of complication
Time frame: from spinal anesthesia till the delivery of the fetus, or within 30 minutes postspinal which comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 37685357Chang 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.
- Background: PubMed 34212308Gagne 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.
- Background: PubMed 26782160Hernandez 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.
- Background: PubMed 29398426Pretorius 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.
- Individual participant dataSharing planned: Yes. de-identified individual participant data (IPD) will be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluid therapy, 300 ml of crystalloid Ringer's solution. in people with Pre-Eclampsia and Hypotension, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wessam selima, MD (01001958858, w.z.selima@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-spinal hypotension (time frame: 20 minutes after the spinal anesthesia injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06539026, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.