Comparison of Intraoperative fluid requirement with Conventional and goal-directed fluid management in neonates undergong laparotomy

Intraoperative Liberal versus Goal-directed Fluid Therapy in Neonates undergoing Laparotomy- A Prospective Randomized Controlled Trial - nil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055007

Enrollment

Registered

2023-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: K566- Other and unspecified intestinal obstruction

Interventions

Intervention1: PVI Monitor: Intraoperative Fluid Management throughout the duration of Surgery Control Intervention1: nil: nil

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term and Late preterm neonates, (GA > 35 weeks) up to 28 days of life. 2. Emergency procedures. 3. Anticipated duration of surgery > 60minutes

Exclusion criteria

Exclusion criteria: 1. Children with associated medical conditions like Cardiac anomaly, Pulmonary anomaly/severe respiratory disease, Hepatic disease 2. Weight 3. Abdominal surgery where visceral exposure is not anticipated. • Anticipated massive blood transfusion. • Hb • Evidence of hypovolemia before induction of anaesthesia. • Preoperative inotropes

Design outcomes

Primary

Measure	Time frame
To compare the total amount of fluid infused intraoperatively in ml/ kg in both the groupsTimepoint: END OF SURGERY	—

Secondary

Measure	Time frame
Duration of hospital stayTimepoint: Postoperative period till the discharge of the patient;Intraoperative lactate & base excess levelsTimepoint: Baseline & at the end of surgery before shifting the patient out of the Operating Room;Recovery of bowel functionTimepoint: Postoperative period till confirmation of bowel sounds;Serum electrolytesTimepoint: Baseline & at the end of surgery before shifting the patient out of the Operating Room	—

Measure

Time frame

Duration of hospital stayTimepoint: Postoperative period till the discharge of the patient;Intraoperative lactate & base excess levelsTimepoint: Baseline & at the end of surgery before shifting the patient out of the Operating Room;Recovery of bowel functionTimepoint: Postoperative period till confirmation of bowel sounds;Serum electrolytesTimepoint: Baseline & at the end of surgery before shifting the patient out of the Operating Room

—

Countries

India

Contacts

Public ContactDr Preethy J Mathew

Postgraduate Institute of Medical Education and Research

tjpreethy@gmail.com9417800203

Outcome results

None listed

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