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Adverse EffectNCT04272632

Coload Optimization Guided by Inferior Vena Cava Collapsibility Index

A study testing 4 ml/kg group, 8 ml/kg group and 12 ml/kg group in people with Adverse Effect, run by General Hospital of Ningxia Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the optimal coload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Adverse Effect
What is being tested?
4 ml/kg group, 8 ml/kg group and 12 ml/kg group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteChina
Study dates
1 Apr 2021to 25 Nov 2021
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 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18-40 years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for elective cesarean section under spinal anesthesia

Who cannot join

  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Trial locations and contacts

1 site in 1 country.

China1 site

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

Other trials in China

About this study

Official title: Coload Optimization Guided by Inferior Vena Cava Collapsibility Index in Parturients With Prophylactic Norepinephrine Infusion Undergoing Cesarean Section: a Randomized, Dose-finding Trial

The purpose of this study is to investigate the optimal coload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Read the detailed description

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, our study (NCT03997500) had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery, suggesting that more prudent fluid management is required. The ideal dose of coload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal coload guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Conditions
Adverse Effect
Being tested
4 ml/kg group, 8 ml/kg group, 12 ml/kg group
Keywords
Coload, Inferior vena cava collapsibility index, Norepinephrine, Cesarean section, Dose-finding

What participants receive

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

  • 4 ml/kg groupDrug

    Also called Crystalloid

    4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

  • 8 ml/kg groupDrug

    Also called Crystalloid

    8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

  • 12 ml/kg groupDrug

    Also called Crystalloid

    12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Study groups in NCT04272632
Study groupRoleWhat they receive
4 ml/kg groupExperimental4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.
Receives: Drug: 4 ml/kg group
8 ml/kg groupExperimental8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.
Receives: Drug: 8 ml/kg group
12 ml/kg groupExperimental12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.
Receives: Drug: 12 ml/kg group

What is being measured

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

  1. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

    Measured: Baseline (before preload)

  2. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

    Measured: Before spinal anesthesia (after preload)

  3. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

    Measured: 5 min after spinal anesthesia

  4. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

    Measured: 5 min after fetal delivery

  5. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

    Measured: Before leaving the operating room

Secondary outcomes (12)

  1. The incidence of post-spinal anesthesia hypotension.

    Systolic blood pressure (SBP) < 80% of the baseline.

    Measured: 1-15 minutes after spinal anesthesia

  2. The incidence of severe post-spinal anesthesia hypotension.

    Systolic blood pressure (SBP) < 60% of the baseline

    Measured: 1-15 minutes after spinal anesthesia

  3. The incidence of nausea and vomiting.

    Presence of nausea and vomiting in patients after spinal anesthesia

    Measured: 1-15 minutes after spinal anesthesia

  4. The incidence of bradycardia

    Heart rate < 55 beats/min.

    Measured: 1-15 minutes after spinal anesthesia

  5. The incidence of hypertension

    Systolic blood pressure (SBP) >120% of the baseline

    Measured: 1-15 minutes after spinal anesthesia

  6. pH

    From umbilical vein blood gases

    Measured: Immediately after delivery

  7. Partial pressure of oxygen

    From umbilical vein blood gases

    Measured: Immediately after delivery

  8. Base excess

    From umbilical vein blood gases

    Measured: Immediately after delivery

  9. APGAR score

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Measured: 1min after delivery

  10. APGAR score

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Measured: 5min after delivery

  11. Overall stability of systolic blood pressure control versus baseline

    Evaluated by performance error (PE).

    Measured: 1-15 minutes after spinal anesthesia.

  12. Overall stability of heart rate control versus baseline

    Evaluated by performance error (PE).

    Measured: 1-15 minutes after spinal anesthesia.

Timeline

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

  1. First posted17 Feb 2020
  2. Study start1 Apr 2021
  3. Primary completion25 Nov 2021
  4. Study completion25 Nov 2021

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
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272632
Sponsor's protocol ID
Yi Chen-2020-3
Status last verified
Feb 2021
First submitted
11 Feb 2020
Last updated
29 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 4 ml/kg group, 8 ml/kg group and 12 ml/kg group in people with Adverse Effect, run by General Hospital of Ningxia Medical University at 1 site in China.

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: finished, as of the sponsor's last update on 29 Nov 2021. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC) (time frame: Baseline (before preload)). The study lists 5 primary outcomes in all. 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 NCT04272632.

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 Nov 2021.

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