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Comparison between two types of hemodynamic management in patients undergoing surgery for brain aneurysm, in order to observe the effect on post-operative kidney function

Effect of Hyotension Prediction Index (HPI) based algorithm versus conventional pulse pressure variation (PPV) based hemodynamic management on incidence of acute kidney injury in patients undergoing cerebral aneurysm clipping surgery: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078175
Enrollment
104
Registered
2024-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified Health Condition 2: G968- Other specified disorders of central nervous system

Interventions

Intervention1: Hypotension prediction index (HPI) based algorithm: In group H arterial cannula will be transduced to an HPI monitor and management will be done as per study protocol (Figure 1). Firs

Sponsors

Post Graduate Institute of Meducal Education and Research, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Written informed consent b) Patient aged 18 years or more c) ASA 1, ASA 2 physical status d) Patients with aSAH undergoing clipping surgery including all SAH grades

Exclusion criteria

Exclusion criteria: a) Refuse to give consent for enrolling in the study b) Hemodynamically unstable patients on vasopressor or ionotropic support in preoperative period c) Patients with pre-existing morphological or interstitial renal pathology or chronic kidney disease, severe hepatic and cardiac dysfunction d) Pregnant patients e) Patient with uncontrolled DM, Congestive heart failure and active cardiac disease. F) Refuse to give consent for enrolling in the study

Design outcomes

Primary

MeasureTime frame
Comparison of the incidence of AKI (according to KDIGO AKI Staging) in both the groups Timepoint: At 1,2,3 and 7 days after surgery

Secondary

MeasureTime frame
Comparison of incidence of intraoperative time weighted average mean arterial pressure (MAP) less than 65 mm Hg (TWA-AUT-65)Timepoint: on day of operation;Comparison of vasopressors and inotropic medication used in intraoperative period and during study periodTimepoint: from day of operation till end of 7 days;Comparison of value of serum creatinine postoperativelyTimepoint: At 24, 48, 72 hours and on postoperative day 7;Comparison of biomarker TIMP-2 and NGAL levels between the two study groupsTimepoint: On day of surgery before anesthetic induction and after 7 days postoperatively;Comparison of Perioperative fluid intake and blood losTimepoint: On day of operation;Incidence of SAH between good grade and poor grade SAHTimepoint: from day of operation till 7 days postoperatively;length of hospital stay and intensive care unit stayTimepoint: from day of operation until discharge of patient from hospital or death of patient in hospital (whichever earlier);Glasgow coma Extended (GOSE) scoreTimepoint: after 3 months from operation;modified Rankin score (mRS)Timepoint: At discharge from hospital

Countries

India

Contacts

Public ContactShiv Lal Soni

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH

dr.shivsoni@gmail.com7087003413

Outcome results

None listed

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