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a comparison of total fluid given by goal directed fluid therapy and conventional therapy in head injury patients undergoing surgery- a randomised controlled trial

A comparison of the total intra operative fluid administered by goal directed fluid therapy and conventional fluid therapy in isolated traumatic brain injury patients undergoing early decompressive craniectomy- a prospective randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031242
Enrollment
64
Registered
2021-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Goal directed fluid therapy: goal directed fluid therapy using Stroke volume variation, cardiac index and mean arterial pressure Control Intervention1: Conventional fluid therapy: flui

Sponsors

Postgraduate institute of medical education and research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: isolated traumatic brain injury undergoing decompressive craniectomy within 24 hours of trauma

Exclusion criteria

Exclusion criteria: active coronary artery disease, documented severe valvular disease, atrial fibrillation or flutter, acute renal dysfunction, documented or history of severe portal hypertension, significant pulmonary insufficiency, pregnancy, extreme body mass index i.e. >45 or <17, blunt trauma abdomen and chest, spontaneous breathing and tidal volumes <8ml/kg

Design outcomes

Primary

MeasureTime frame
To compare total fluid administered in goal-directed therapy and conventional hemodynamic based therapy on total intra-operative fluid administered in isolated traumatic brain injury patients undergoing early decompressive craniectomy surgeryTimepoint: end of surgery—

Secondary

MeasureTime frame
To compare total days on ventilator, days in ICU and total hospital stayTimepoint: till discharge;1. To compare total blood loss, lactate, urine output and hematocritTimepoint: during surgery;To compare GOS at three months post dischargeTimepoint: 3 months post discharge;To compare the FOUR score when the patient will be on ventilatorTimepoint: till extubation;To compare the use of vasoactive drugsTimepoint: during surgery—

Countries

India

Contacts

Public ContactDhatri Jonna

Postgraduate institute of medical education and research

amarjyotiorama@gmail.com9618063357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026