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

Hypotension Drug-Induced Clinical Trial

Official title:

Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03478618
• Other study ID #: haemodynamics in preeclampsia
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: March 21, 2018
• Last updated: March 21, 2018
• Start date: March 2018
• Est. completion date: April 2019

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: Zein El Abadin Zarae Hassan, PhD
• Phone: 01005187371
• Email: zein20002002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypotension
• Hypotension Drug-Induced

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of hypotension	decrease in systolic blood pressure more than 20% of base line	1 hour