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Comparison comparatively less amount of fluid therapy and liberal fluid therapy on kidney function parameters in patients who are taken for Major Abdominal and Gynaecological: A prospective Randomised Clinical Trial

Comparison of Restrictive Fluid Therapy versus Conventional Fluid therapy on Renal Indices In Patients undergoing Major Abdominal & Gynaecological Surgeries: A Prospective Randomised Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032579
Enrollment
60
Registered
2021-04-06
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: C19- Malignant neoplasm of rectosigmoidjunction

Interventions

Intervention1: Restrictive (â??zero balanceâ??) intravenous fluid therapy: The restrictive group fluid regimen was designed to provide 2.0 L water and 120 mmol sodium per day. Induction of anaesthesia
no other intravenous fluids will be used at the initiation of surgery (unless indicated by goal-directed device). Hartmanns solution or comparable balanced salt crystalloid at 5 mL/kg/hour will be adm
then a postoperative infusion rate of 0.8 mL/kg/hour until cessation of intravenous fluid therapy within 24 hours. The rate of postoperative fluid replacement can be reduced if there will be evidence

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: We will include the following patients: Adults (>=18 years) of either sex undergoing elective major Abdominal & Gynaecological surgeries. All these patients have increased risk of postoperative complications, defined by at least one of the following criteria: age >=70 years known or documented history of coronary artery disease known or documented history of heart failure diabetes currently treated with an oral hypoglycemic agent and/or insulin preoperative serum creatinine >200 μmol/L ( >2.8 mg/dL) morbid obesity (body mass index [BMI] >=35 kg/m2) preoperative serum albumin anaerobic threshold (if performed) or two or more of the following risk factors: â??â??American Society of Anesthesiologists (ASA) physical status 3 or 4 â??â??chronic respiratory disease â??â??obesity (BMI 30â??35 kg/m2) â??â??aortic or peripheral vascular disease â??â??preoperative hemoglobin â??â??preoperative serum creatinine 150â??199 μmol/L ( >1.7 mg/dL) â??â??anaerobic threshold (if performed) 12â??14 mL/kg/min.

Exclusion criteria

Exclusion criteria: We will apply the following exclusion criteria: Urgent or time-critical surgery ASA physical status 5 Chronic renal failure requiring dialysis Liver resection Minor or intermediate surgery,

Design outcomes

Primary

MeasureTime frame
change serum creatinine and cystatin -CTimepoint: in 72 hours

Secondary

MeasureTime frame
Delta change in serum sodium, potassium and chloride levelsTimepoint: with in 48 hours

Countries

India

Contacts

Public ContactAjit Kumar

AIIMS RISHIKESH

ajitdr.ajit@gmail.com9910789377

Outcome results

None listed

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