Intraoperative liberal versus goal directed fluid therapy in neonates

Intraoperative liberal versus goal directed fluid therapy in neonates - A prospective randomised controlled trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023561

Enrollment

Registered

2020-02-25

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: P788- Other specified perinatal digestive system disorders

Interventions

Intervention1: Goal directed fluid therapy: Pleth variability index will be used to assess fluid responsiveness intra-operatively to guide fluid administration Control Intervention1: Liberal fluid the

Eligibility

Inclusion criteria

Inclusion criteria: Term neonates undergoing emergency abdominal surgeries

Exclusion criteria

Exclusion criteria: CDH, TEF, Neonates with congenital heart disease, hemodynamically unstable neonates on inotropes, neonates with heart failure or respiratory disorders, creatinine clearance less than 90ml/min

Design outcomes

Primary

Measure	Time frame
Comparison of the total amount of fluid infused intra-operatively in both the groupsTimepoint: At the end of surgery	—

Secondary

Measure	Time frame
Intraoperative lactate, pH, HCO3, base excess and sodium levelsTimepoint: At the beginning and end of surgery;Intraoperative urine outputTimepoint: At the end of surgery;Intraoperative use of dopamineTimepoint: At the end of surgery;Postoperative complications pertaining to tissue perfusion (anastomotic leak, delayed wound healing)Timepoint: At the time of discharge;Postoperative duration of hospital stayTimepoint: At the time of discharge;Postoperative recovery of bowel function (flatus time/ return of bowel sounds)Timepoint: At the time of discharge;Serum electrolytes, Blood urea and Serum creatinine levelsTimepoint: Before and after surgery	—

Measure

Time frame

Intraoperative lactate, pH, HCO3, base excess and sodium levelsTimepoint: At the beginning and end of surgery;Intraoperative urine outputTimepoint: At the end of surgery;Intraoperative use of dopamineTimepoint: At the end of surgery;Postoperative complications pertaining to tissue perfusion (anastomotic leak, delayed wound healing)Timepoint: At the time of discharge;Postoperative duration of hospital stayTimepoint: At the time of discharge;Postoperative recovery of bowel function (flatus time/ return of bowel sounds)Timepoint: At the time of discharge;Serum electrolytes, Blood urea and Serum creatinine levelsTimepoint: Before and after surgery

—

Countries

India

Contacts

Public ContactDr Swathy A S

PGIMER

neerja.bhardwaj@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026