Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia
Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2018
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMarch 27, 2018
March 1, 2018
1 year
March 21, 2018
March 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of hypotension
decrease in systolic blood pressure more than 20% of base line
1 hour
Study Arms (2)
Group R
ACTIVE COMPARATOR30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative.
Group L
ACTIVE COMPARATOR30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative.
Interventions
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
Eligibility Criteria
You may qualify if:
- more than 36 weeks gestation
- singleton pregnant women planned for elective caesarian section
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 18333521BACKGROUNDGanesan 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.
PMID: 21240869BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 21, 2018
First Posted
March 27, 2018
Study Start
March 1, 2018
Primary Completion
March 1, 2019
Study Completion
April 1, 2019
Last Updated
March 27, 2018
Record last verified: 2018-03