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A clinical study to see the effects of two different methods of fluid administration (Fluid volume estimated by anaesthetist compared with volume estimated by a machine) during Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy

A Prospective Randomized Control Trial of Goal directed Vs Standard Fluid Therapy in Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027296
Enrollment
72
Registered
2020-08-21
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: C18- Malignant neoplasm of colon Health Condition 2: C56- Malignant neoplasm of ovary Health Condition 3: C25- Malignant neoplasm of pancreas Health Condition 4: C20- Malignant neoplasm of rectum Health Condition 5: C17- Malignant neoplasm of small intestine Health Condition 6: C16- Malignant neoplasm of stomach

Interventions

Intervention1: Stroke volume variation (SVV) (using Flotrac) guided fluid therapy: The CI will be maintained at values greater than or equal to 2.5 l/min/m2 , stroke volume variation 12%, Stroke Volu

Sponsors

Dr BRAIRCH AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Agree to participate in the study and sign written informed consent. 2.Age of 18 -70 years. 3.ASA-PS grade I or II patients posted for CRS and HIPEC surgery.

Exclusion criteria

Exclusion criteria: 1.Known case of liver dysfunction (liver enzymes three times the normal ) or renal dysfunction (Creatinine two times the normal) 2.Known coagulation disorder. (Platelet 1.5) 3.COPD with FEV1 4.Psychiatric disorders. 5.Left Ventricular Ejection Fraction 6.If surgical resection level of cc0/cc1 cannot be achieved. 7.Contraindications of epidural anesthesia. 8.Allergic to any drug used during the study.

Design outcomes

Primary

MeasureTime frame
Serum Lactate levelsTimepoint: At baseline, then at one hour interval during Cytoreductive phase, half hourly interval during HIPEC phase and every 6 hourly interval post operatively for 24 hours.—

Secondary

MeasureTime frame
â?¢ Post-operative renal complication will be decided by AKIN staging system of acute kidney injury.Timepoint: For this Kidney function tests will be done immediately after surgery and at 24 hours post surgery. Also, plasma NGAL levels will be measured at the baseline, immediately after surgery and then at 24 hours after surgery.;Post-operative 30 day mortality.Timepoint: Upto 30 days.;Post-operative length of ICU stayTimepoint: Till fit to discharge depending on the discretion of ICU physician.—

Countries

India

Contacts

Public ContactDr Raghav Gupta

Dr. BRAIRCH AIIMS, New Delhi

sushmabhatnagar1@gmail.com9811326453

Outcome results

None listed

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