Comparison of two different methods for guiding intravenous fluid administration during intracranial aneurysmal clipping surgeries

Phase 2

• Conditions: Health Condition 1: I607- Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery

• Registration Number: CTRI/2022/01/039086
• Lead Sponsor: GIPMER New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients within age group of 18- 65 years who are diagnosed with aneurysmal subarachnoid hemorrhage

2.Require craniotomy for clipping of ruptured intracranial anterior circulation aneurysm under general anaesthesia.

Exclusion Criteria

1.Patient/relatives refusal

2.Known case of Coronary Artery disease

3.Hunt and Hess grade more than 3.

4.Moderate and severe systolic dysfunction(Ejection Fraction < 40%)

5.Grade 3 and grade 4 diastolic dysfunction

6.Malignant arrhythmias

7.Valvular heart defects

8.Cardiomyopathies

9.Stunned myocardium due to neurocardiogenic effect of Subarachnoid hemorrhage

10.Patients with end organ dysfunction (hepatic and renal impairment)

11.Poorly controlled hypertension

12.Morbid obesity ( BMI > 35 )

13.Severe Chronic Obstructive Pulmonary Disease with Cor-pulmonale

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Comparison of total intravenous fluid administered between the groups receiving LVOT-VTI measured by TTE based fluid therapy with CVP guided fluid therapy <br/ ><br>2.Differences between number of episodes of hypotension ( MAP 65 mm hg or more than 20% decrease from baseline ) between the groups receiving LVOT-VTI measured by TTE based fluid therapy with CVP guided fluid therapy <br/ ><br>Timepoint: End of Surgery

Secondary Outcome Measures

Name	Time	Method
Base deficit(mmol/l)Timepoint: Baseline,End of surgery;Extended Glasgow outcome scaleTimepoint: 30 Days;ICU length of stay (days)Timepoint: At time of Discharge from hospital;In hospital mortalityTimepoint: At time of Discharge;Incidence of cerebral vasospasmTimepoint: At time of discharge from ICU;Mean arterial blood pressure <br/ ><br>(mm hg) <br/ ><br> <br/ ><br>Timepoint: 5 Minute Interval;Modified Rankin scaleTimepoint: At Discharge from Hospital;Serum lactate (mmol/lTimepoint: Baseline,End of surgery;Total urine output ( ml) <br/ ><br>Timepoint: End of Surgery