A study to see the effect of an intravenous fluid used in hip surgery on kidney function and clotting parameters

Changes in postoperative renal function and coagulation profile after hydroxyethyl starch administration in patients undergoing orthopaedic hip surgery under spinal anaesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/020890

Enrollment

Registered

2019-08-26

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: M849- Disorder of continuity of bone, unspecified

Interventions

Intervention1: 130/0.4 6% Hydroxyethylstarch as coloading: One day prior to the surgery, investigations will be done include Hb, BT, CT,Hematocrit, platelet count, PT/INR, serum creatinine, blood urea

Eligibility

Inclusion criteria

Inclusion criteria: A total of 70 patients aged 50-80 years undergoing orthopaedic hip surgery under spinal anaesthesia

Exclusion criteria

Exclusion criteria: ASA 3 or 4, chronic kidney disease, preexisting hematological disease, low platelet count, coagulopathy, pulmonary diseases, cardiovascular diseases, hepatic diseases

Design outcomes

Primary

Measure	Time frame
To observe postoperative changes in 1.Serum creatinine 2.blood urea 3.Glomerular filtration rate 4.Hematocrit 5.BT 6.CT 7.Platelet count 8.PT/INRTimepoint: At first all the above investigation of patients will be done one day prior to the surgery, then on the day of surgery after surgery (Day 1 ) and then on third day of surgery ( Day 3 ) and then all the above data will be assessed for both ringer lactate and 130/0.4% HES group. Data will be compiled and appropriate statistical test will be used to analyse the results.	—

Measure

Time frame

To observe postoperative changes in 1.Serum creatinine 2.blood urea 3.Glomerular filtration rate 4.Hematocrit 5.BT 6.CT 7.Platelet count 8.PT/INRTimepoint: At first all the above investigation of patients will be done one day prior to the surgery, then on the day of surgery after surgery (Day 1 ) and then on third day of surgery ( Day 3 ) and then all the above data will be assessed for both ringer lactate and 130/0.4% HES group. Data will be compiled and appropriate statistical test will be used to analyse the results.

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Secondary

Measure	Time frame
To observe postoperative changes in 1.Serum creatinine 2.blood urea 3.Glomerular filtration rate 4.Hematocrit 5.BT 6.CT 7.Platelet count 8.PT/INRTimepoint: All the above investigations will be done first one day prior to the surgery, then on the day of surgery after surgery ( Day 1 ) and then on the 3rd day of surgery( Day 3 ) and data will be assessed for both ringer lactate and 130/0.4% HES. Data will be compiled and appropriate statistical test will be used to analyse the results.	—

Measure

Time frame

To observe postoperative changes in 1.Serum creatinine 2.blood urea 3.Glomerular filtration rate 4.Hematocrit 5.BT 6.CT 7.Platelet count 8.PT/INRTimepoint: All the above investigations will be done first one day prior to the surgery, then on the day of surgery after surgery ( Day 1 ) and then on the 3rd day of surgery( Day 3 ) and data will be assessed for both ringer lactate and 130/0.4% HES. Data will be compiled and appropriate statistical test will be used to analyse the results.

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Countries

India

Contacts

Public ContactDr Monika Bhandari

Pt B D Sharma PGIMS Rohtak Haryana

monikabhandari584@gmail.com9756368804

Outcome results

None listed

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