Effect of Early Intraoperative Administration of drug increasing blood pressure on Organ Dysfunction after abdominal surgery

Early Vasopressor Administration And Postoperative Organ Dysfunction In Elective Abdominal Surgery: A Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075534

Enrollment

110

Registered

2024-10-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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: Early Noradrenaline infusion: The study will follow the standard hospital procedures and protocols for surgery, anaesthesia, and perioperative care. All patients will undergo invasive a

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 to 70 years undergoing elective major open abdominal surgery with general anaesthesia with expected surgical duration of more than 120 minutes

Exclusion criteria

Exclusion criteria: 1)Patients who decline to give consent. 2)Patients with poorly controlled hypertension 3)K/c/o CAD, CKD, CLD 4)Patients with primary end organ dysfunction. 5)Patients on monoamine oxidase inhibitors 6)Patients who were pregnant or breastfeeding. 7)Patients with phaechromocytoma/paraganglionoma

Design outcomes

Primary

Measure	Time frame
To assess the difference in severity of organ dysfunction in the first seven postoperative days between the two groups using the mean SOFA scoreTimepoint: 7 days	—

Secondary

Measure	Time frame
Difference in 28-day mortality between the groupsTimepoint: 28 days;Difference in cumulative fluid balance at Day7Timepoint: 7 days;Difference in duration of mechanical ventilationTimepoint: 28 days;Difference in incidence of AKITimepoint: 28 days;Difference in intraoperative blood lossTimepoint: Duration of surgery;Difference in lactate levels lactate level at end of surgery, 24 post-opTimepoint: at the end of surgery , 24 hours;Difference in length of hospital stay between the groupsTimepoint: Day 28;Difference in mean I-FEED score at day 7 and time to GI-2 recoveryTimepoint: 7 days;Difference in organ failure free days (no need for vasopressors, NIV/IMV or RRT)Timepoint: 28 days;Difference in the individual components of the primary outcomeTimepoint: 7 days;Difference in total fluid infusedTimepoint: 24 hours;Difference in unplanned ICU stay between the groups.Timepoint: 28 days;P/F ratio at end of surgery and at 24h post opTimepoint: at the end of surgery , 24 hours	—

Measure

Time frame

Difference in 28-day mortality between the groupsTimepoint: 28 days;Difference in cumulative fluid balance at Day7Timepoint: 7 days;Difference in duration of mechanical ventilationTimepoint: 28 days;Difference in incidence of AKITimepoint: 28 days;Difference in intraoperative blood lossTimepoint: Duration of surgery;Difference in lactate levels lactate level at end of surgery, 24 post-opTimepoint: at the end of surgery , 24 hours;Difference in length of hospital stay between the groupsTimepoint: Day 28;Difference in mean I-FEED score at day 7 and time to GI-2 recoveryTimepoint: 7 days;Difference in organ failure free days (no need for vasopressors, NIV/IMV or RRT)Timepoint: 28 days;Difference in the individual components of the primary outcomeTimepoint: 7 days;Difference in total fluid infusedTimepoint: 24 hours;Difference in unplanned ICU stay between the groups.Timepoint: 28 days;P/F ratio at end of surgery and at 24h post opTimepoint: at the end of surgery , 24 hours

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Countries

India

Contacts

Public ContactDivya N

AIIMS,New Delhi

drrahulkanand@gmail.com9013082271

Outcome results

None listed

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