NCT04272580

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2021

Completed
Last Updated

July 6, 2021

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

February 11, 2020

Last Update Submit

July 1, 2021

Conditions

Adverse Effect

Keywords

PreloadInferior vena cava collapsibility indexNorepinephrineCesarean sectionDose-finding

Outcome Measures

Primary Outcomes (5)

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

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

    Baseline (before preload)

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

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

    Before spinal anesthesia (after preload)

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

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

    5 min after spinal anesthesia

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

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

    5 min after fetal delivery

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

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

    Before leaving the operating room

Secondary Outcomes (12)

  • The incidence of post-spinal anesthesia hypotension.

    1-15 minutes after spinal anesthesia

  • The incidence of severe post-spinal anesthesia hypotension.

    1-15 minutes after spinal anesthesia.

  • The incidence of nausea and vomiting.

    1-15 minutes after spinal anesthesia.

  • The incidence of bradycardia

    1-15 minutes after spinal anesthesia

  • The incidence of hypertension

    1-15 minutes after spinal anesthesia

  • +7 more secondary outcomes

Study Arms (4)

Control group

SHAM COMPARATOR

No preload was given before spinal anesthesia

Drug: Control group

4 ml/kg group

EXPERIMENTAL

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

Drug: 4 ml/kg group.

8 ml/kg group

EXPERIMENTAL

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

Drug: 8 ml/kg group.

12 ml/kg group

EXPERIMENTAL

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

Drug: 12 ml/kg group.

Interventions

Control groupDRUG

No preload was given before spinal anesthesia.

Also known as: Crystalloid
Control group
4 ml/kg group.DRUG

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

Also known as: Crystalloid
4 ml/kg group
8 ml/kg group.DRUG

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

Also known as: Crystalloid
8 ml/kg group
12 ml/kg group.DRUG

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

Also known as: Crystalloid
12 ml/kg group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Control GroupsCrystalloid SolutionsPopulation Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsIsotonic SolutionsSolutionsPharmaceutical PreparationsDemographyPopulation Characteristics

Study Officials

  • Xinli Ni, Dr.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 17, 2020

Study Start

July 1, 2020

Primary Completion

March 27, 2021

Study Completion

March 27, 2021

Last Updated

July 6, 2021

Record last verified: 2020-02

Locations

CN(1)