Pregnancy RelatedNCT04330742
The Effect of Fluids on Aortic VTI During C-section
An observational study of Pregnancy Related and Hemorrhage, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Pregnancy is associated with a myriad of physiologic changes, including expansion of blood volume, decrease in oncotic pressure, and increased cardiac output. The obstetric population is associated with intrapartum hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Hemorrhage, Fluid Overload
- What is being tested?
- lactated ringers
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 31 Dec 2025
- Phase
- Observational
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients ages 18-35 undergoing elective cesarean section with planned spinal anesthetic at Ben Taub General Hospital (BTGH) will be screened. Consenting patients will undergo spinal anesthetic prior to planned procedure. All subjects will receive the same 1L fluid bolus intraoperatively.
Who may be able to join
- healthy nulliparous or multiparous pregnant women with a term (>37 weeks gestation)
- age 18-35
- singleton pregnancy
- scheduled for Cesarean delivery with planned neuraxial spinal or combined spinal epidural anesthesia
- American Society for Anesthesiologists physical status 2
Who cannot join
- Patients without ability to provide informed consent
- American Society for Anesthesiologists physical status 3 or 4
- Emergency cesarean section
- BMI>40
- Known cardiac and pulmonary comorbidities including chronic hypertension, preeclampsia, gestational hypertension, diabetes, asthma, renal disease
- Age > 35
Trial locations and contacts
1 site in 1 country.
Claudia Wei, MD contact
United States1 site, 1 recruiting
- Recruiting
Ben Taub General Hospital
Houston, Texas, 77030
Claudia Wei, MD, cwei@bcm.edu
Amy Lee, MD, 713-793-8805, Amy.Lee@bcm.edu
About this study
Official title: The Influence of Intravascular Fluid Administration on Aortic Velocity Time Integral in Obstetric Patients Undergoing Cesarean Section
Pregnancy is associated with a myriad of physiologic changes, including expansion of blood volume, decrease in oncotic pressure, and increased cardiac output. The obstetric population is associated with intrapartum hemorrhage. Accordingly, it is important to have an accurate method to assess fluid status in intrapartum patients. The use of standard volume assessment tools including arterial lines and central venous catheters is limited given the brevity of obstetric procedures and the morbidity of these techniques on the awake patients, and the costs. Non-invasive methods to assess volume status (carotid dopplers, direct measurement of blood loss, bio-impedance devices) are imperfect. Echocardiography is an attractive tool to measure fluid status in experienced operators such as anesthesiologists. IVC diameter and variation of aortic velocity time integral are two measures that can be obtained via echocardiography and been studied in spontaneously breathing patients. The purpose of this study is to determine whether these measurements can be used in the assessment of volume status in the laboring patient.
Read the detailed description
Pregnancy is associated with a myriad of physiologic changes, including expansion of blood volume, decrease in oncotic pressure, and increased cardiac output. Comorbidities including maternal hypertension, renal or cardiac disease may further complicate the assessment of volume status and are associated with increased risks related to fluid administration (c). In addition, the majority of obstetric patients receive neuraxial analgesia or anesthesia to facilitate both vaginal and operative delivery. These techniques are associated with hemodynamic changes including maternal hypotension secondary to a decrease in SVR and CO. These changes may in turn be associated with a reduction in placental blood flow affecting fetal outcome, and may also cause maternal nausea, vomiting and dizziness. Further, the obstetric population is high risk for intrapartum hemorrhage. As such, it is critical to have an accurate method to assess fluid status in intrapartum patients.
The use of invasive volume assessment tools including arterial lines and central venous catheters is limited given the brevity of obstetric procedures, the morbidity of these invasive techniques for the awake patient, and the associated time and costs (b). Non-invasive methods that assess volume status in the obstetric population include techniques such as direct measurement of blood loss (g), carotid dopplers (c), bio-impedence devices (f); However these methods have been shown to be imperfect and are not widely used.
Echocardiography is a non-invasive, widely-available tool that can provide rapid information for experienced operators such as anesthesiologists. Respiratory variations in inferior vena cava diameter (IVCd) and variation in aortic velocity time integral (∆VTI) following passive leg raise have been extensively studied in spontaneously breathing patients. IVCd has been shown to predict fluid responsiveness, however requires a high threshold (>40-50% collapsibility) to detect a difference. IVCd may also change with diaphragmatic motion, thus results may be confounded if the patient becomes tachypneic (d) or is spontaneously breathing (g). In contrast, aortic velocity time integral (∆VTI) may be a more sensitive indicator of volume status. Lamia et al showed a 12% change in VTI as 77% sensitive and 100% specific for a 15% change in cardiac output following 500 mL volume expansion in ICU patients with shock (both spontaneously breathing and mechanically ventilated, e). While there are some studies of IVC collapsibility in the obstetric population, there are limited data on VTI as a measure of volume status in laboring patients.
The purpose of this study is to determine whether the aortic velocity time integral (VTI) is influenced by intravascular fluid administration during cesarean section. Secondary aims include determining whether inferior vena cava diameter (IVCd), blood pressure, and heart rate are influenced by intravascular fluid administration during cesarean section. Additionally, total amount of vasopressor agents administered during the procedure will be recorded.
- Conditions
- Pregnancy Related, Hemorrhage, Fluid Overload, Labor Complication
- Being tested
- lactated ringers
- Keywords
- obstetrics, fluid responsiveness, fluid resuscitation
- Medical subject headings
- Hemorrhage, Edema, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactated ringersDrug
Also called crystalloid
the intervention is one liter fluid bag of lactated ringers which is routinely used as a fluid coload for spinal anesthesia. All patients will receive the same amount of fluids however this will be paused at various time points in order to perform the echocardiogram.
| Study group | Role | What they receive |
|---|---|---|
| 0 mL crystalloid | These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 0, at which time 0 mL of fluids will have been administered. Receives: Drug: lactated ringers | |
| 250 mL crystalloid. | These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 1, after the spinal has been placed and approximately 250 mL fluids has been administered. Receives: Drug: lactated ringers | |
| 500 mL crystalloid | These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 2, at which time 500 mL of fluids will have been administered. Receives: Drug: lactated ringers | |
| 1000 mL crystalloid | These are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 3, at which time 1000 mL of fluids will have been administered. Receives: Drug: lactated ringers |
What is being measured
The primary outcome is the main question the study is designed to answer.
aortic velocity time integral
the percent change in aortic velocity time integral as measured by transthoracic echo
Measured: at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins)
Secondary outcomes (3)
inferior vena cava collapsibility
the percent change in diameter of inferior vena cava as measured by transthoracic echo
Measured: at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins)
change in systolic blood pressure
percent change in systolic blood pressure
Measured: every 2.5 mins for 20 mins (when 1L LR is administered) once the pt has a spinal placement
change in heart rate
percent change in heart rate
Measured: every 2.5 mins for 20 mins (when 1L LR is administered) once the pt has a spinal placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start25 Mar 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Lee, Baylor College of Medicine
- Investigators
- Amy Lee, MD, Principal investigator, Baylor College of MedicineYi Deng, MD, Study director, Baylor College of MedicineClaudia Wei, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330742
- Sponsor's protocol ID
- H45744
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2020
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ngan Kee WD, Khaw KS, Ng FF. Prevention of hypotension during spinal anesthesia for cesarean delivery: an effective technique using combination phenylephrine infusion and crystalloid cohydration. Anesthesiology. 2005 Oct;103(4):744-50. doi: 10.1097/00000542-200510000-00012.
PubMed 16192766Zieleskiewicz L, Noel A, Duclos G, Haddam M, Delmas A, Bechis C, Loundou A, Blanc J, Mignon A, Bouvet L, Einav S, Bourgoin A, Leone M. Can point-of-care ultrasound predict spinal hypotension during caesarean section? A prospective observational study. Anaesthesia. 2018 Jan;73(1):15-22. doi: 10.1111/anae.14063. Epub 2017 Oct 7.
PubMed 28986931Zieleskiewicz L, Bouvet L, Einav S, Duclos G, Leone M. Diagnostic point-of-care ultrasound: applications in obstetric anaesthetic management. Anaesthesia. 2018 Oct;73(10):1265-1279. doi: 10.1111/anae.14354. Epub 2018 Jul 26.
PubMed 30047997Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17.
PubMed 17508199McIntyre JP, Ellyett KM, Mitchell EA, Quill GM, Thompson JM, Stewart AW, Doughty RN, Stone PR; Maternal Sleep in Pregnancy Study Group. Validation of thoracic impedance cardiography by echocardiography in healthy late pregnancy. BMC Pregnancy Childbirth. 2015 Mar 28;15:70. doi: 10.1186/s12884-015-0504-5.
PubMed 25886289Hancock A, Weeks AD, Lavender DT. Is accurate and reliable blood loss estimation the 'crucial step' in early detection of postpartum haemorrhage: an integrative review of the literature. BMC Pregnancy Childbirth. 2015 Sep 28;15:230. doi: 10.1186/s12884-015-0653-6.
PubMed 26415952Airapetian N, Maizel J, Alyamani O, Mahjoub Y, Lorne E, Levrard M, Ammenouche N, Seydi A, Tinturier F, Lobjoie E, Dupont H, Slama M. Does inferior vena cava respiratory variability predict fluid responsiveness in spontaneously breathing patients? Crit Care. 2015 Nov 13;19:400. doi: 10.1186/s13054-015-1100-9.
PubMed 26563768Brun C, Zieleskiewicz L, Textoris J, Muller L, Bellefleur JP, Antonini F, Tourret M, Ortega D, Vellin A, Lefrant JY, Boubli L, Bretelle F, Martin C, Leone M. Prediction of fluid responsiveness in severe preeclamptic patients with oliguria. Intensive Care Med. 2013 Apr;39(4):593-600. doi: 10.1007/s00134-012-2770-2. Epub 2012 Dec 6.
PubMed 23223774Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.
PubMed 23043910Maizel J, Airapetian N, Lorne E, Tribouilloy C, Massy Z, Slama M. Diagnosis of central hypovolemia by using passive leg raising. Intensive Care Med. 2007 Jul;33(7):1133-1138. doi: 10.1007/s00134-007-0642-y. Epub 2007 May 17.
PubMed 17508202Gardin JM, Davidson DM, Rohan MK, Butman S, Knoll M, Garcia R, Dubria S, Gardin SK, Henry WL. Relationship between age, body size, gender, and blood pressure and Doppler flow measurements in the aorta and pulmonary artery. Am Heart J. 1987 Jan;113(1):101-9. doi: 10.1016/0002-8703(87)90016-0.
PubMed 2948377Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.
PubMed 29461392Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
PubMed 26580836
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Intravascular Fluid Administration on Aortic Velocity Time Integral in Obstetric Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT04330742
- Acronym / sponsor ID
- H45744
- Conditions
- Pregnancy Related, Hemorrhage, Fluid Overload, Labor Complication
- Keywords
- obstetrics, fluid responsiveness, fluid resuscitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Apr 2020 (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.
Pregnancy is associated with a myriad of physiologic changes, including expansion of blood volume, decrease in oncotic pressure, and increased cardiac output. The obstetric population is associated with intrapartum hemorrhage. Accordingly, it is important to have an accurate method to assess fluid status in intrapartum patients. The use of standard volume assessment tools including arterial lines and central venous catheters is limited given the brevity of obstetric procedures and the morbidity of these techniques on the awake patients, and the costs. Non-invasive methods to assess volume status (carotid dopplers, direct measurement of blood loss, bio-impedance devices) are imperfect. Echocardiography is an attractive tool to measure fluid status in experienced operators such as anesthesiologists. IVC diameter and variation of aortic velocity time integral are two measures that can be obtained via echocardiography and been studied in spontaneously breathing patients. The purpose of this study is to determine whether these measurements can be used in the assessment of volume status in the laboring patient.
Detailed description
Pregnancy is associated with a myriad of physiologic changes, including expansion of blood volume, decrease in oncotic pressure, and increased cardiac output. Comorbidities including maternal hypertension, renal or cardiac disease may further complicate the assessment of volume status and are associated with increased risks related to fluid administration (c). In addition, the majority of obstetric patients receive neuraxial analgesia or anesthesia to facilitate both vaginal and operative delivery. These techniques are associated with hemodynamic changes including maternal hypotension secondary to a decrease in SVR and CO. These changes may in turn be associated with a reduction in placental blood flow affecting fetal outcome, and may also cause maternal nausea, vomiting and dizziness. Further, the obstetric population is high risk for intrapartum hemorrhage. As such, it is critical to have an accurate method to assess fluid status in intrapartum patients.
The use of invasive volume assessment tools including arterial lines and central venous catheters is limited given the brevity of obstetric procedures, the morbidity of these invasive techniques for the awake patient, and the associated time and costs (b). Non-invasive methods that assess volume status in the obstetric population include techniques such as direct measurement of blood loss (g), carotid dopplers (c), bio-impedence devices (f); However these methods have been shown to be imperfect and are not widely used.
Echocardiography is a non-invasive, widely-available tool that can provide rapid information for experienced operators such as anesthesiologists. Respiratory variations in inferior vena cava diameter (IVCd) and variation in aortic velocity time integral (∆VTI) following passive leg raise have been extensively studied in spontaneously breathing patients. IVCd has been shown to predict fluid responsiveness, however requires a high threshold (>40-50% collapsibility) to detect a difference. IVCd may also change with diaphragmatic motion, thus results may be confounded if the patient becomes tachypneic (d) or is spontaneously breathing (g). In contrast, aortic velocity time integral (∆VTI) may be a more sensitive indicator of volume status. Lamia et al showed a 12% change in VTI as 77% sensitive and 100% specific for a 15% change in cardiac output following 500 mL volume expansion in ICU patients with shock (both spontaneously breathing and mechanically ventilated, e). While there are some studies of IVC collapsibility in the obstetric population, there are limited data on VTI as a measure of volume status in laboring patients.
The purpose of this study is to determine whether the aortic velocity time integral (VTI) is influenced by intravascular fluid administration during cesarean section. Secondary aims include determining whether inferior vena cava diameter (IVCd), blood pressure, and heart rate are influenced by intravascular fluid administration during cesarean section. Additionally, total amount of vasopressor agents administered during the procedure will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 mL crystalloid | – | Drug: lactated ringersThese are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 0, at which time 0 mL of fluids will have been administered. |
| 250 mL crystalloid. | – | Drug: lactated ringersThese are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 1, after the spinal has been placed and approximately 250 mL fluids has been administered. |
| 500 mL crystalloid | – | Drug: lactated ringersThese are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 2, at which time 500 mL of fluids will have been administered. |
| 1000 mL crystalloid | – | Drug: lactated ringersThese are the measurements (aortic velocity time integral, inferior vena cava diameter, vital signs) that will be taken at time 3, at which time 1000 mL of fluids will have been administered. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients ages 18-35 undergoing elective cesarean section with planned spinal anesthetic at Ben Taub General Hospital (BTGH) will be screened. Consenting patients will undergo spinal anesthetic prior to planned procedure. All subjects will receive the same 1L fluid bolus intraoperatively.
Key inclusion criteria (5 listed)
- healthy nulliparous or multiparous pregnant women with a term (>37 weeks gestation)
- age 18-35
- singleton pregnancy
- scheduled for Cesarean delivery with planned neuraxial spinal or combined spinal epidural anesthesia
- American Society for Anesthesiologists physical status 2
Key exclusion criteria (6 listed)
- Patients without ability to provide informed consent
- American Society for Anesthesiologists physical status 3 or 4
- Emergency cesarean section
- BMI>40
- Known cardiac and pulmonary comorbidities including chronic hypertension, preeclampsia, gestational hypertension, diabetes, asthma, renal disease
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 |
|---|---|---|
| lactated ringersAlso: crystalloidthe intervention is one liter fluid bag of lactated ringers which is routinely used as a fluid coload for spinal anesthesia. All patients will receive the same amount of fluids however this will be paused at various time points in order to perform the echocardiogram. | Drug | 0 mL crystalloid, 1000 mL crystalloid, 250 mL crystalloid., 500 mL crystalloid |
Primary outcome
aortic velocity time integral
Time frame: at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins)
the percent change in aortic velocity time integral as measured by transthoracic echo
3 secondary outcomes
inferior vena cava collapsibility
Time frame: at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins)
change in systolic blood pressure
Time frame: every 2.5 mins for 20 mins (when 1L LR is administered) once the pt has a spinal placement
change in heart rate
Time frame: every 2.5 mins for 20 mins (when 1L LR is administered) once the pt has a spinal placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 16192766Ngan Kee WD, Khaw KS, Ng FF. Prevention of hypotension during spinal anesthesia for cesarean delivery: an effective technique using combination phenylephrine infusion and crystalloid cohydration. Anesthesiology. 2005 Oct;103(4):744-50. doi: 10.1097/00000542-200510000-00012.
- Background: PubMed 28986931Zieleskiewicz L, Noel A, Duclos G, Haddam M, Delmas A, Bechis C, Loundou A, Blanc J, Mignon A, Bouvet L, Einav S, Bourgoin A, Leone M. Can point-of-care ultrasound predict spinal hypotension during caesarean section? A prospective observational study. Anaesthesia. 2018 Jan;73(1):15-22. doi: 10.1111/anae.14063. Epub 2017 Oct 7.
- Background: PubMed 30047997Zieleskiewicz L, Bouvet L, Einav S, Duclos G, Leone M. Diagnostic point-of-care ultrasound: applications in obstetric anaesthetic management. Anaesthesia. 2018 Oct;73(10):1265-1279. doi: 10.1111/anae.14354. Epub 2018 Jul 26.
- Background: PubMed 17508199Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17.
- Background: PubMed 25886289McIntyre JP, Ellyett KM, Mitchell EA, Quill GM, Thompson JM, Stewart AW, Doughty RN, Stone PR; Maternal Sleep in Pregnancy Study Group. Validation of thoracic impedance cardiography by echocardiography in healthy late pregnancy. BMC Pregnancy Childbirth. 2015 Mar 28;15:70. doi: 10.1186/s12884-015-0504-5.
- Background: PubMed 26415952Hancock A, Weeks AD, Lavender DT. Is accurate and reliable blood loss estimation the 'crucial step' in early detection of postpartum haemorrhage: an integrative review of the literature. BMC Pregnancy Childbirth. 2015 Sep 28;15:230. doi: 10.1186/s12884-015-0653-6.
- Background: PubMed 26563768Airapetian N, Maizel J, Alyamani O, Mahjoub Y, Lorne E, Levrard M, Ammenouche N, Seydi A, Tinturier F, Lobjoie E, Dupont H, Slama M. Does inferior vena cava respiratory variability predict fluid responsiveness in spontaneously breathing patients? Crit Care. 2015 Nov 13;19:400. doi: 10.1186/s13054-015-1100-9.
- Background: PubMed 23223774Brun C, Zieleskiewicz L, Textoris J, Muller L, Bellefleur JP, Antonini F, Tourret M, Ortega D, Vellin A, Lefrant JY, Boubli L, Bretelle F, Martin C, Leone M. Prediction of fluid responsiveness in severe preeclamptic patients with oliguria. Intensive Care Med. 2013 Apr;39(4):593-600. doi: 10.1007/s00134-012-2770-2. Epub 2012 Dec 6.
- Background: PubMed 23043910Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.
- Background: PubMed 17508202Maizel J, Airapetian N, Lorne E, Tribouilloy C, Massy Z, Slama M. Diagnosis of central hypovolemia by using passive leg raising. Intensive Care Med. 2007 Jul;33(7):1133-1138. doi: 10.1007/s00134-007-0642-y. Epub 2007 May 17.
- Background: PubMed 2948377Gardin JM, Davidson DM, Rohan MK, Butman S, Knoll M, Garcia R, Dubria S, Gardin SK, Henry WL. Relationship between age, body size, gender, and blood pressure and Doppler flow measurements in the aorta and pulmonary artery. Am Heart J. 1987 Jan;113(1):101-9. doi: 10.1016/0002-8703(87)90016-0.
- Background: PubMed 29461392Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.
- Individual participant dataSharing planned: No
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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.
Claudia Wei, MD contact
Amy Lee, MD principal investigator
Baylor College of Medicine
Yi Deng, MD study director
Baylor College of Medicine
Claudia Wei, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Hemorrhage, run by Baylor College of Medicine at 1 site in United States.
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 5 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 22 Apr 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 United States. 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 Amy Lee, MD (713-793-8805, amy.lee@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aortic velocity time integral (time frame: at baseline measure, right after spinal placement (250mL LR), at 500mL LR infusion, and at 1 L LR infusion (approximately 20mins)). 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 NCT04330742, which also lists 13 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 22 Apr 2024.