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Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia

Primary Purpose

Pregnancy, Cesarean Delivery, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Crystalloid
Colloid
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia.

Exclusion Criteria:

  • multiple pregnancy

    • gestational age < 36 weeks

      • preexisting or pregnancy-induced hypertension

        • Morbid cardiovascular impairments

          • Cerebrovascular disease

            ⑥ Known fetal anomaly

            ⑦ Contraindications to spinal anesthesia

            ⑧ Any sign of onset of labor

            ⑨ Body weight < 45 kg or body weight > 90 kg

            ⑩ Height < 145cm or height > 180cm

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crystalloid

Colloid

Arm Description

Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia.

Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia.

Outcomes

Primary Outcome Measures

Incidence of maternal hypotension
defined as: Systolic Blood Pressure (SBP) < 80% of baseline SBP

Secondary Outcome Measures

incidence of severe hypotension
defined as: Systolic Blood Pressure (SBP) < 70% of baseline SBP
incidence of symptomatic hypotension
defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness
incidence of bradycardia
Heart Rate (HR) <50 bpm
incidence of Hypertension
Systolic Blood Pressure (SBP)> 120% of baseline SBP
Minimum recorded Systolic Blood Pressure (Minimum SBP)
The lowest recorded SBP during the time period from induction of spinal anesthesia until delivery
Minimum recorded Heart Rate (Minimum HR)
The lowest recorded HR during the time period from induction of spinal anesthesia until delivery
Cumulative duration of hypotension
duration of hypotension, minutes
Onset time of hypotension
Time from the induction of spinal anesthesia until the first event of hypotension occur
Total phenylephrine use
Cumulative dose of phenylephrine administered via continuous infusion, mcg
Rescue phenylephrine use
number of patients who require the rescue use of phenylephrine
Rescue ephedrine use
number of patients who require the rescue use of ephedrine
Atropine use
number of patients who require the rescue use of atropine
Incidence of nausea, vomiting
The incidence of nausea, vomiting
Incidence of dizziness, breathlessness
The incidence of dizziness, breathlessness
Cutaneous stellate ganglion sympathetic activity
noninvasive recording of skin sympathetic nerve activity (SKNA) using conventional ECG electrodes
Apgar Score, 1 min, 5 min (fetal outcome)
Apgar Score of delivered baby. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are the Appearance, Pulse, Grimace, Activity, and Respiration. Each is scored on a scale of 0 to 2, with 2 being the best score. The test is done at 1 and 5 minutes after birth.
Umbilical arterial pH
pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome)
Umbilical arterial base excess
base excess of Umbilical ABGA (fetal outcome), mmol/L
Umbilical arterial partial oxygen pressure (PO2)
partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg
Umbilical arterial carbon dioxide partial pressure (PCO2)
carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg

Full Information

First Posted
October 28, 2018
Last Updated
January 31, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03729076
Brief Title
Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia
Official Title
Crystalloid Versus Colloid Rapid Co-load in Parturients Receiving Prophylactic Phenylephrine Infusion During Cesarean Delivery Under Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
January 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Cesarean Delivery, Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crystalloid
Arm Type
Experimental
Arm Description
Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia.
Arm Title
Colloid
Arm Type
Active Comparator
Arm Description
Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia.
Intervention Type
Other
Intervention Name(s)
Crystalloid
Intervention Description
Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.
Intervention Type
Other
Intervention Name(s)
Colloid
Intervention Description
Patients will receive the rapid co-loading with 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.
Primary Outcome Measure Information:
Title
Incidence of maternal hypotension
Description
defined as: Systolic Blood Pressure (SBP) < 80% of baseline SBP
Time Frame
during the time period from induction of spinal anesthesia until delivery
Secondary Outcome Measure Information:
Title
incidence of severe hypotension
Description
defined as: Systolic Blood Pressure (SBP) < 70% of baseline SBP
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
incidence of symptomatic hypotension
Description
defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
incidence of bradycardia
Description
Heart Rate (HR) <50 bpm
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
incidence of Hypertension
Description
Systolic Blood Pressure (SBP)> 120% of baseline SBP
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Minimum recorded Systolic Blood Pressure (Minimum SBP)
Description
The lowest recorded SBP during the time period from induction of spinal anesthesia until delivery
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Minimum recorded Heart Rate (Minimum HR)
Description
The lowest recorded HR during the time period from induction of spinal anesthesia until delivery
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Cumulative duration of hypotension
Description
duration of hypotension, minutes
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Onset time of hypotension
Description
Time from the induction of spinal anesthesia until the first event of hypotension occur
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Total phenylephrine use
Description
Cumulative dose of phenylephrine administered via continuous infusion, mcg
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Rescue phenylephrine use
Description
number of patients who require the rescue use of phenylephrine
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Rescue ephedrine use
Description
number of patients who require the rescue use of ephedrine
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Atropine use
Description
number of patients who require the rescue use of atropine
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Incidence of nausea, vomiting
Description
The incidence of nausea, vomiting
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Incidence of dizziness, breathlessness
Description
The incidence of dizziness, breathlessness
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Cutaneous stellate ganglion sympathetic activity
Description
noninvasive recording of skin sympathetic nerve activity (SKNA) using conventional ECG electrodes
Time Frame
during the time period from induction of spinal anesthesia until delivery
Title
Apgar Score, 1 min, 5 min (fetal outcome)
Description
Apgar Score of delivered baby. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are the Appearance, Pulse, Grimace, Activity, and Respiration. Each is scored on a scale of 0 to 2, with 2 being the best score. The test is done at 1 and 5 minutes after birth.
Time Frame
1 min, 5 min after delivery
Title
Umbilical arterial pH
Description
pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome)
Time Frame
immediately after delivery
Title
Umbilical arterial base excess
Description
base excess of Umbilical ABGA (fetal outcome), mmol/L
Time Frame
immediately after delivery
Title
Umbilical arterial partial oxygen pressure (PO2)
Description
partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg
Time Frame
immediately after delivery
Title
Umbilical arterial carbon dioxide partial pressure (PCO2)
Description
carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg
Time Frame
immediately after delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Parturients
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia. Exclusion Criteria: multiple pregnancy gestational age < 36 weeks preexisting or pregnancy-induced hypertension Morbid cardiovascular impairments Cerebrovascular disease ⑥ Known fetal anomaly ⑦ Contraindications to spinal anesthesia ⑧ Any sign of onset of labor ⑨ Body weight < 45 kg or body weight > 90 kg ⑩ Height < 145cm or height > 180cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29090733
Citation
Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
Results Reference
background
PubMed Identifier
25501602
Citation
Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.
Results Reference
background
PubMed Identifier
29461392
Citation
Tawfik 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.
Results Reference
background
PubMed Identifier
27670627
Citation
Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.
Results Reference
background

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Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia

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