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Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia

Primary Purpose

Hypotension Drug-Induced

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Lactated Ringer
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension Drug-Induced

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • more than 36 weeks gestation
  • singleton pregnant women planned for elective caesarian section

Exclusion Criteria:

  • patient refusal.
  • psychiatric disorders.
  • parturient <36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing.
  • absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group R

    Group L

    Arm Description

    30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative.

    30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative.

    Outcomes

    Primary Outcome Measures

    incidence of hypotension
    decrease in systolic blood pressure more than 20% of base line

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2018
    Last Updated
    March 21, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03478618
    Brief Title
    Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia
    Official Title
    Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    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
    To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension Drug-Induced

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group R
    Arm Type
    Active Comparator
    Arm Description
    30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative.
    Arm Title
    Group L
    Arm Type
    Active Comparator
    Arm Description
    30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative.
    Intervention Type
    Drug
    Intervention Name(s)
    Lactated Ringer
    Intervention Description
    Patients will be divided into 2 groups according to the amount of fluids received during caesarian section under spinal anesthesia. Group (R) 30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. Group (L) 30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. blood loss will be replaced if more than 500 ml in ratio 3 ml crystalloid : 1ml blood in both groups
    Primary Outcome Measure Information:
    Title
    incidence of hypotension
    Description
    decrease in systolic blood pressure more than 20% of base line
    Time Frame
    1 hour

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: more than 36 weeks gestation singleton pregnant women planned for elective caesarian section Exclusion Criteria: patient refusal. psychiatric disorders. parturient <36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing. absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zein El Abadin Zarae Hassan, PhD
    Phone
    01005187371
    Email
    zein20002002@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18333521
    Citation
    Ansari MR, Laghari MS, Solangi KB. Acute renal failure in pregnancy: one year observational study at Liaquat University Hospital, Hyderabad. J Pak Med Assoc. 2008 Feb;58(2):61-4.
    Results Reference
    background
    PubMed Identifier
    21240869
    Citation
    Ganesan C, Maynard SE. Acute kidney injury in pregnancy: the thrombotic microangiopathies. J Nephrol. 2011 Sep-Oct;24(5):554-63. doi: 10.5301/JN.2011.6250.
    Results Reference
    background

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    Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia

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