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

NCT ID: NCT03478618

Last Updated: 2018-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2019-04-30

Brief Summary

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

Detailed Description

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Conditions

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Hypotension Drug-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group R

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

Group Type ACTIVE_COMPARATOR

Lactated Ringer

Intervention Type DRUG

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

Group L

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

Group Type ACTIVE_COMPARATOR

Lactated Ringer

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Bola Fawzi Mekhail Sedrak

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Zein El Abadin Zarae Hassan, PhD

Role: CONTACT

01005187371

References

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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.

Reference Type BACKGROUND
PMID: 18333521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21240869 (View on PubMed)

Other Identifiers

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haemodynamics in preeclampsia

Identifier Type: -

Identifier Source: org_study_id

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