AzTrials
AzTrials

Cardiac Output,LowEarly Phase 1NCT02759510

Cardiac Output Changes in Cesarean Section

A Early Phase 1 study testing Norepinephrine and Phenylephrine in people with Cardiac Output,Low and Hemodynamic Instability, run by RenJi Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure in obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result in cardiac output (CO) reduction.Norepinephrine… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Norepinephrine and Phenylephrine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
No sites listed yet
Study dates
Jun 2016to Jun 2017
Phase
Early Phase 1
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 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • age >=18 years,<=40 years;
  • height 150-180 cm;
  • weight 55-80 kg;
  • full-term gestation (>36 wk and <41 wk)
  • singleton pregnancy undergoing elective cesarean section under CSEA

Who cannot join

  • contraindications to spinal anesthesia;
  • patients with any complicated pregnancy;
  • fetal compromise;
  • need of emergency;
  • in labor

Trial locations and contacts

No sites are listed yet.

Qionghui Zhan, MD contact

8621-34506285

zhanqionghui328@163.com

About this study

Official title: Comparison of Norepinephrine and Phenylephrine in Cesarean Section by Transesophageal Ultrasound

Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure in obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result in cardiac output (CO) reduction.Norepinephrine acts not only as an α adrenoceptor receptor agonist, but also as a weaker β adrenergic receptor agonist. It can elevate blood pressure the same asphenylephrine, meanwhile produce positive inotropic effect including increasing heart rate.Thus, the administration of norepinephrine can maintain blood pressue and avoid the decline of CO. The purpose of this study is to evaluate the effect of norepinephrine and phenylephrine on maternal CO in cesarean section by transesophageal echocardiography.

Read the detailed description

Combined spinal epidural anesthesia (CSEA) is a commonly used anesthetic methods in cesarean section. The main problem of CSEA is hypotension, which will cause maternal nausea and vomiting, reduced uteroplacental blood flow and fetal acidosis. One of the important methods for prevention and treatment of hypotension after CSEA is to give vasoactive drugs.

Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure in obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result in cardiac output (CO) reduction.Dyer et al. used bioimpedance technique to analyze the hemodynamic changes in normal pregnant women. A bolus of 80 ug phenylephrine was administrated when maternal mean arterial pressure decreased 20% after CSEA. It was found that cardiac output (CO) decreased significantly (14%) after phenylephrine administrationcompared with the baseline.And the decrease of CO induced by phenylephrine was in a dose dependent.All the studies referred above recruitednormal pregnant women, and the decreased CO did not have an adverse effect on neonatal birth. However, as we all know, the decrease of CO will influence uteroplacental blood, which may lead to adverse results in existed intrauterine distress fetal. All authors of those studies stressed that the decrease of CO induced by phenylephrine may increase the risks of fetal distress or other adverse consequences. So, it is crucial for obstetric anesthesiologist to choose a suitable vasoactive drugs, which can maintain both maternal blood pressure and uteroplacental perfusion in order to keep intrauterine environment steady.

Norepinephrine acts not only as an α adrenoceptor receptor agonist, but also as a weaker β adrenergic receptor agonist. It can elevate blood pressure the same asphenylephrine, meanwhile produce positive inotropic effect including increasing heart rate.Thus, the administration of norepinephrine can maintain blood pressue and avoid the decline of CO. And norepinephrine is superior to phenylephrine in the respect of organ perfusion.

There is little research about the administration of norepinephrine in obstetric anesthesia.Ngan Kee et al.compared phenylephrine (0.57μg/kg/min) with norepinephrine (0.035μg/kg/min) in the treatment of hypotension in obstetric anesthesia. CO monitored by a suprasternal Doppler ultrasound every 5 minutes. CO and heart rate was significantly higher in norepinephrine group than that in phenylephrine group, while peripheral vascular resistance was significantly lower in norepinephrine group than that in phenylephrine group. And the oxygen content in umbilical venous was significantly higher in norepinephrine group, which may be related to the norepinephrine induced lower peripheral vascular resistance and high cardiac output.Monitoring of CO can give a comprehensive understanding of hemodynamics in the pregnant. It enables obstetric anesthesiologist to use liquid expansion rationally and administrate vasoactive agents properly.Although the accuracy of suprasternal Doppler ultrasound was high in that study, the interval of 5min to monitor CO may miss the rapid changes in hemodynamics of pregnant women.In the present study, we will monitor CO continuously by a small diameter (6 mm) transesophageal echocardiography, which can be retained in the patient's esophagus.

The purpose of this study is to evaluate the effect of norepinephrine and phenylephrine on maternal CO in cesarean section by transesophageal echocardiography.Fetal umbilical cord blood, neonatal 1min Apgar score, 5 min Apgar scores and neonatal plasma catecholamine concentrations will be collected to understand the effects of norepinephrine and phenylephrine on fetal.

Being tested
Norepinephrine, Phenylephrine
Keywords
cardiac output, norepinephrin, cesarean section
Medical subject headings
Cardiac Output, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NorepinephrineDrug

    Hypotension (systolic BP <80% of baseline) will be treated with intravenous boluses of norepinephrine 2 μg.

  • PhenylephrineDrug

    Hypotension (systolic BP <80% of baseline) will be treated with intravenous boluses of phenylephrine 40 μg.

Study groups in NCT02759510
Study groupRoleWhat they receive
phenylephrineActive comparatorphenylejphrine (one bolus for 40 ug/ml)
Receives: Drug: Phenylephrine
norepinephrineExperimentalnorepinephrine (one bolus for 2 ug/ml)
Receives: Drug: Norepinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiac output

    Measured: from baseline (before spinal injection) until 10 minutes after spinal injection

Secondary outcomes (5)
  1. systolic blood pressure

    Measured: from baseline (before spinal injection) until 10 minutes after spinal injection

  2. heart rate

    Measured: from baseline (before spinal injection) until 10 minutes after spinal injection

  3. Apgar score

    Measured: 1 min and 5 min after delivery

  4. Umbilical cord arterial blood pH/BE/Lac

    Measured: time at delivery

  5. umbilical plasma catecholamine concentration

    Measured: time at delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02759510
Sponsor's protocol ID
Renji-2016035k
Status last verified
Apr 2016
First submitted
29 Apr 2016
Last updated
3 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Norepinephrine and Phenylephrine in people with Cardiac Output,Low and Hemodynamic Instability, run by RenJi Hospital.

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 5 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 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Qionghui Zhan, MD (8621-34506285, zhanqionghui328@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiac output (time frame: from baseline (before spinal injection) until 10 minutes after spinal injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 May 2016.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in