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

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ClinicalTrials.gov Identifier: NCT03478618
Recruitment Status : Unknown
Verified March 2018 by Bola Fawzi Mekhail Sedrak, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bola Fawzi Mekhail Sedrak, Assiut University

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

Condition or disease Intervention/treatment Phase
Hypotension Drug-Induced Drug: Lactated Ringer Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group R
30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative.
 Drug: Lactated Ringer

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
Active Comparator: Group L
30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative.
 Drug: Lactated Ringer

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


Outcome Measures
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Primary Outcome Measures :
  1. incidence of hypotension [ Time Frame: 1 hour ]
    decrease in systolic blood pressure more than 20% of base line


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478618


Contacts
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Contact: Zein El Abadin Zarae Hassan, PhD 01005187371 zein20002002@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Bola Fawzi Mekhail Sedrak, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03478618    
Other Study ID Numbers: haemodynamics in preeclampsia
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases